Trial Outcomes & Findings for Dronabinol in Total Knee Arthroplasty (TKA) (NCT NCT04734080)
NCT ID: NCT04734080
Last Updated: 2026-03-27
Results Overview
The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
24-48 hours post-operatively
Results posted on
2026-03-27
Participant Flow
Subject enrollment began on 03/09/2021 and ended on 10/04/2023. The last subject follow-up was completed on 04/01/2024.
Participant milestones
| Measure |
Dronabinol
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
|
Placebo
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
55
|
56
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dronabinol in Total Knee Arthroplasty (TKA)
Baseline characteristics by cohort
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=56 Participants
|
63 years
n=62 Participants
|
63 years
n=123 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=56 Participants
|
26 Participants
n=62 Participants
|
58 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=56 Participants
|
30 Participants
n=62 Participants
|
53 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
9 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=56 Participants
|
50 Participants
n=62 Participants
|
98 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
8 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=56 Participants
|
48 Participants
n=62 Participants
|
92 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
|
American Society of Anesthesiologists (ASA) Class
1
|
0 participants
n=56 Participants
|
1 participants
n=62 Participants
|
1 participants
n=123 Participants
|
|
American Society of Anesthesiologists (ASA) Class
2
|
54 participants
n=56 Participants
|
53 participants
n=62 Participants
|
107 participants
n=123 Participants
|
|
American Society of Anesthesiologists (ASA) Class
3
|
1 participants
n=56 Participants
|
2 participants
n=62 Participants
|
3 participants
n=123 Participants
|
|
Body Mass Index
|
30.9 kg/m^2
n=56 Participants
|
29.3 kg/m^2
n=62 Participants
|
29.8 kg/m^2
n=123 Participants
|
PRIMARY outcome
Timeframe: 24-48 hours post-operativelyPopulation: Participants were lost to follow up/withdrawn.
The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time.
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Cumulative Opioid Consumption 24-48 Hours Post-operatively
|
8 morphine milligram equivalents
Interval 7.5 to 30.0
|
15 morphine milligram equivalents
Interval 7.5 to 30.0
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)-DischargePopulation: Participants were lost to follow up/withdrawn.
Time to reach discharge physical therapy goals, as defined by the number of hours required to meet the following criteria: stable vital signs during Physical therapy (PT), safe independent transfer from bed to standing as well as transfer in and out of seated position, ability to walk 40 feet only with aid of crutch or walker. This outcome will be measured prior to patient discharge.
Outcome measures
| Measure |
Dronabinol
n=53 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=53 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Time to Reach Discharge From Physical Therapy
|
19.4 hours
Interval 17.8 to 23.1
|
20.6 hours
Interval 17.5 to 23.8
|
SECONDARY outcome
Timeframe: Post operative day 1, 2, 7, 90 and 180Population: Participants were lost to follow up/withdrawn.
Patient pain with ambulation on postoperative day (POD) 1, 2, 7, 90 and 180, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
POD180
|
1.50 units on a scale
Standard Error 0.39
|
1.51 units on a scale
Standard Error 0.38
|
|
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
POD7
|
4.46 units on a scale
Standard Error 0.43
|
4.97 units on a scale
Standard Error 0.39
|
|
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
POD90
|
1.91 units on a scale
Standard Error 0.34
|
1.58 units on a scale
Standard Error 0.29
|
|
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
POD1
|
3.63 units on a scale
Standard Error 0.36
|
4.04 units on a scale
Standard Error 4.41
|
|
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
POD2
|
5.68 units on a scale
Standard Error 0.36
|
6.40 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180Population: Participants were lost to follow up/withdrawn.
Patient pain at rest upon PACU entry and in the morning of postoperative day (POD)1, POD2, POD7, POD90 and POD180 defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
PACU
|
2.13 units on a scale
Standard Error 0.41
|
1.75 units on a scale
Standard Error 0.40
|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
POD1
|
1.39 units on a scale
Standard Error 0.28
|
1.54 units on a scale
Standard Error 0.30
|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
POD2
|
2.21 units on a scale
Standard Error 0.35
|
2.18 units on a scale
Standard Error 0.29
|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
POD7
|
1.43 units on a scale
Standard Error 0.26
|
1.47 units on a scale
Standard Error 0.31
|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
POD90
|
0.62 units on a scale
Standard Error 0.20
|
0.42 units on a scale
Standard Error 0.23
|
|
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
POD180
|
0.25 units on a scale
Standard Error 0.15
|
0.27 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Postoperative Day 1 and Postoperative Day 2Population: Participants were lost to follow up/withdrawn.
Patient pain during morning physical therapy on postoperative day (POD)1 and 2, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Pain With Physical Therapy
POD2
|
5.04 units on a scale
Standard Error 0.42
|
5.30 units on a scale
Standard Error 0.40
|
|
Pain With Physical Therapy
POD1
|
3.09 units on a scale
Standard Error 0.33
|
3.54 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)-DischargePopulation: Participants were lost to follow up/withdrawn.
Hospital length of stay from procedure start time to time of discharge
Outcome measures
| Measure |
Dronabinol
n=54 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=54 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Length of Hospital Stay (Hours)
|
26.1 hours
Interval 23.5 to 29.9
|
25.2 hours
Interval 23.0 to 29.0
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)-48 hours post operative dischargePopulation: Participants were lost to follow up/withdrawn.
Postoperative desaturation events are defined as the number of times oxygen saturation dropped below 88% for at least 20 seconds or more. The number of such events will be counted per subject during the monitoring period, beginning in the immediate postoperative period on postoperative day (POD)0 (in the PACU) and will continue until the end post operative day 2/patient discharge, whichever occurs first. Oxygen desaturation is defined when measured SpO2 is less than 88%. Measurements will only be recorded if the desaturation event happens for 20 seconds or longer.
Outcome measures
| Measure |
Dronabinol
n=53 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=54 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
the Number of Desaturation Events
|
1 number of events
Interval 0.0 to 6.0
|
2.5 number of events
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative dischargePopulation: Participants were lost to follow up/withdrawn.
PainOut assesses post-surgical pain by collecting data on pain intensity, interference with daily activities, and other related factors. Questionnaire uses multiple scales from 0 (none/not at all/did not interfere/extremely dissatisfied) to 10 (extreme/severe/worst pain imaginable/completely interfered/extremely satisfied). Pain severity/Interference/Symptom questions are scored from 0-10, with higher scores indicating worse outcomes. With a scale of 0-10, higher scores indicate better outcomes for the following questions: decision participation question and satisfaction question. The following questions used a scale of 1-11, where 1=0% and 11=100%: Pain relief (a higher percentage indicates better outcome) Time with severe pain (a higher percentage indicates worse outcome)
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
PainOUT Scale Questions
Interference with doing activities in bed, such as turning, sitting up, and changing position POD1
|
1.04 score on a scale
Standard Error 0.30
|
1.01 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Interference with doing activities in bed, such as turning, sitting up, and changing position POD90
|
1.22 score on a scale
Standard Error 0.32
|
0.53 score on a scale
Standard Error 0.27
|
|
PainOUT Scale Questions
Interference with sleeping POD7
|
2.52 score on a scale
Standard Error 0.42
|
2.42 score on a scale
Standard Error 0.43
|
|
PainOUT Scale Questions
Pain causing patients to feel anxious POD1
|
0.29 score on a scale
Standard Error 0.15
|
0.42 score on a scale
Standard Error 0.21
|
|
PainOUT Scale Questions
Pain causing patients to feel anxious POD180
|
0.15 score on a scale
Standard Error 0.15
|
0.36 score on a scale
Standard Error 0.21
|
|
PainOUT Scale Questions
Participation in decisions about pain treatment POD180
|
9.54 score on a scale
Standard Error 0.30
|
9.54 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Satisfaction with results of pain management treatment POD180
|
9.23 score on a scale
Standard Error 0.32
|
8.79 score on a scale
Standard Error 0.34
|
|
PainOUT Scale Questions
Pain relief POD1
|
10.08 score on a scale
Standard Error 0.23
|
9.89 score on a scale
Standard Error 0.37
|
|
PainOUT Scale Questions
Worst Pain: POD1
|
3.92 score on a scale
Standard Error 0.38
|
4.64 score on a scale
Standard Error 0.43
|
|
PainOUT Scale Questions
Worst Pain: POD2
|
6.08 score on a scale
Standard Error 0.37
|
5.95 score on a scale
Standard Error 0.42
|
|
PainOUT Scale Questions
Worst Pain: POD7
|
4.92 score on a scale
Standard Error 0.40
|
5.32 score on a scale
Standard Error 0.42
|
|
PainOUT Scale Questions
Worst Pain: POD90
|
2.06 score on a scale
Standard Error 0.37
|
1.39 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Worst Pain: POD180
|
1.41 score on a scale
Standard Error 0.41
|
1.10 score on a scale
Standard Error 0.36
|
|
PainOUT Scale Questions
Least Pain: POD1
|
0.77 score on a scale
Standard Error 0.22
|
1.13 score on a scale
Standard Error 0.27
|
|
PainOUT Scale Questions
Least Pain: POD2
|
2.24 score on a scale
Standard Error 0.37
|
2.28 score on a scale
Standard Error 0.38
|
|
PainOUT Scale Questions
Least Pain: POD7
|
1.23 score on a scale
Standard Error 0.23
|
1.48 score on a scale
Standard Error 0.30
|
|
PainOUT Scale Questions
Least Pain: POD90
|
0.91 score on a scale
Standard Error 0.26
|
0.70 score on a scale
Standard Error 0.27
|
|
PainOUT Scale Questions
Least Pain: POD180
|
0.26 score on a scale
Standard Error 0.17
|
0.55 score on a scale
Standard Error 0.18
|
|
PainOUT Scale Questions
Interference with doing activities in bed, such as turning, sitting up, and changing position POD2
|
2.68 score on a scale
Standard Error 0.46
|
2.65 score on a scale
Standard Error 0.40
|
|
PainOUT Scale Questions
Interference with doing activities in bed, such as turning, sitting up, and changing position POD7
|
2.39 score on a scale
Standard Error 0.38
|
2.09 score on a scale
Standard Error 0.36
|
|
PainOUT Scale Questions
Interference with doing activities in bed: turning, sitting up, and changing position POD180
|
1.00 score on a scale
Standard Error 0.32
|
0.43 score on a scale
Standard Error 0.18
|
|
PainOUT Scale Questions
Interference with breathing deeply or coughing POD1
|
0.00 score on a scale
Standard Error NA
It is non-estimable because of all the data at this time point for Dronabinol patients was 0.
|
0.23 score on a scale
Standard Error 0.14
|
|
PainOUT Scale Questions
Interference with breathing deeply or coughing POD2
|
0.38 score on a scale
Standard Error 0.23
|
0.15 score on a scale
Standard Error 0.15
|
|
PainOUT Scale Questions
Interference with breathing deeply or coughing POD7
|
0.08 score on a scale
Standard Error 0.08
|
0.13 score on a scale
Standard Error 0.08
|
|
PainOUT Scale Questions
Interference with breathing deeply or coughing POD90
|
0.12 score on a scale
Standard Error 0.09
|
0.00 score on a scale
Standard Error 0.002
|
|
PainOUT Scale Questions
Interference with breathing deeply or coughing POD180
|
0.01 score on a scale
Standard Error 0.006
|
0.003 score on a scale
Standard Error 0.004
|
|
PainOUT Scale Questions
Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD7
|
2.12 score on a scale
Standard Error 0.35
|
1.76 score on a scale
Standard Error 0.31
|
|
PainOUT Scale Questions
Interference with sleeping POD1
|
1.06 score on a scale
Standard Error 0.31
|
1.06 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Interference with sleeping POD2
|
2.77 score on a scale
Standard Error 0.47
|
2.67 score on a scale
Standard Error 0.46
|
|
PainOUT Scale Questions
Interference with sleeping POD90
|
0.85 score on a scale
Standard Error 0.26
|
0.84 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Interference with sleeping POD180
|
0.55 score on a scale
Standard Error 0.28
|
0.30 score on a scale
Standard Error 0.21
|
|
PainOUT Scale Questions
Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD1
|
1.06 score on a scale
Standard Error 0.36
|
1.23 score on a scale
Standard Error 0.30
|
|
PainOUT Scale Questions
Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD2
|
2.03 score on a scale
Standard Error 0.40
|
2.39 score on a scale
Standard Error 0.39
|
|
PainOUT Scale Questions
Interference with doing activities out of bed:walking, sitting in a chair, standing at a sink POD90
|
0.72 score on a scale
Standard Error 0.24
|
0.18 score on a scale
Standard Error 0.10
|
|
PainOUT Scale Questions
Interference with doing activities out of bed:walking, sitting in a chair,standing at a sink POD180
|
0.43 score on a scale
Standard Error 0.22
|
0.43 score on a scale
Standard Error 0.22
|
|
PainOUT Scale Questions
Pain causing patients to feel anxious POD2
|
0.76 score on a scale
Standard Error 0.29
|
0.33 score on a scale
Standard Error 0.18
|
|
PainOUT Scale Questions
Nausea POD1
|
1.26 score on a scale
Standard Error 0.38
|
0.91 score on a scale
Standard Error 0.31
|
|
PainOUT Scale Questions
Pain causing patients to feel anxious POD7
|
0.34 score on a scale
Standard Error 0.18
|
0.31 score on a scale
Standard Error 0.17
|
|
PainOUT Scale Questions
Pain causing patients to feel anxious POD90
|
0.03 score on a scale
Standard Error 0.02
|
0.0001 score on a scale
Standard Error 0.0034
|
|
PainOUT Scale Questions
Pain causing patients to feel helpless POD1
|
0.23 score on a scale
Standard Error 0.15
|
0.25 score on a scale
Standard Error 0.16
|
|
PainOUT Scale Questions
Pain causing patients to feel helpless POD2
|
0.52 score on a scale
Standard Error 0.27
|
0.02 score on a scale
Standard Error 0.02
|
|
PainOUT Scale Questions
Pain causing patients to feel helpless POD7
|
0.08 score on a scale
Standard Error 0.08
|
0.13 score on a scale
Standard Error 0.09
|
|
PainOUT Scale Questions
Pain causing patients to feel helpless POD90
|
0.00 score on a scale
Standard Error 0.00
|
0.00 score on a scale
Standard Error 0.00
|
|
PainOUT Scale Questions
Pain causing patients to feel helpless POD180
|
0.00 score on a scale
Standard Error 0.00
|
0.23 score on a scale
Standard Error 0.17
|
|
PainOUT Scale Questions
Nausea POD2
|
0.87 score on a scale
Standard Error 0.34
|
1.05 score on a scale
Standard Error 0.34
|
|
PainOUT Scale Questions
Nausea POD7
|
0.62 score on a scale
Standard Error 0.21
|
0.52 score on a scale
Standard Error 0.23
|
|
PainOUT Scale Questions
Nausea POD90
|
0.02 score on a scale
Standard Error 0.06
|
0.04 score on a scale
Standard Error 0.04
|
|
PainOUT Scale Questions
Nausea POD180
|
0.07 score on a scale
Standard Error 0.05
|
0.17 score on a scale
Standard Error 0.16
|
|
PainOUT Scale Questions
Drowsiness POD1
|
1.25 score on a scale
Standard Error 0.34
|
1.38 score on a scale
Standard Error 0.36
|
|
PainOUT Scale Questions
Drowsiness POD2
|
1.22 score on a scale
Standard Error 0.33
|
1.07 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Drowsiness POD7
|
0.84 score on a scale
Standard Error 0.23
|
0.63 score on a scale
Standard Error 0.22
|
|
PainOUT Scale Questions
Drowsiness POD90
|
0.03 score on a scale
Standard Error 0.03
|
0.01 score on a scale
Standard Error 0.03
|
|
PainOUT Scale Questions
Drowsiness POD180
|
0.06 score on a scale
Standard Error 0.05
|
0.05 score on a scale
Standard Error 0.08
|
|
PainOUT Scale Questions
Itching POD1
|
0.32 score on a scale
Standard Error 0.14
|
0.09 score on a scale
Standard Error 0.07
|
|
PainOUT Scale Questions
Itching POD2
|
0.32 score on a scale
Standard Error 0.15
|
0.16 score on a scale
Standard Error 0.13
|
|
PainOUT Scale Questions
Itching POD7
|
0.55 score on a scale
Standard Error 0.18
|
0.48 score on a scale
Standard Error 0.20
|
|
PainOUT Scale Questions
Itching POD90
|
0.52 score on a scale
Standard Error 0.25
|
0.11 score on a scale
Standard Error 0.11
|
|
PainOUT Scale Questions
Itching POD180
|
0.33 score on a scale
Standard Error 0.26
|
0.01 score on a scale
Standard Error 0.01
|
|
PainOUT Scale Questions
Dizziness POD1
|
0.85 score on a scale
Standard Error 0.31
|
0.58 score on a scale
Standard Error 0.24
|
|
PainOUT Scale Questions
Dizziness POD2
|
0.54 score on a scale
Standard Error 0.24
|
0.76 score on a scale
Standard Error 0.25
|
|
PainOUT Scale Questions
Dizziness POD7
|
0.22 score on a scale
Standard Error 0.14
|
0.34 score on a scale
Standard Error 0.16
|
|
PainOUT Scale Questions
Dizziness POD90
|
0.12 score on a scale
Standard Error 0.12
|
0.00 score on a scale
Standard Error 0.02
|
|
PainOUT Scale Questions
Dizziness POD180
|
0.00 score on a scale
Standard Error 0.05
|
0.03 score on a scale
Standard Error 0.03
|
|
PainOUT Scale Questions
Participation in decisions about pain treatment POD1
|
9.77 score on a scale
Standard Error 0.14
|
9.31 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Participation in decisions about pain treatment POD2
|
9.78 score on a scale
Standard Error 0.09
|
9.72 score on a scale
Standard Error 0.12
|
|
PainOUT Scale Questions
Participation in decisions about pain treatment POD7
|
9.56 score on a scale
Standard Error 0.21
|
9.63 score on a scale
Standard Error 0.11
|
|
PainOUT Scale Questions
Participation in decisions about pain treatment POD90
|
9.53 score on a scale
Standard Error 0.24
|
9.02 score on a scale
Standard Error 0.36
|
|
PainOUT Scale Questions
Satisfaction with results of pain management treatment POD1
|
9.67 score on a scale
Standard Error 0.12
|
9.35 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Satisfaction with results of pain management treatment POD2
|
9.23 score on a scale
Standard Error 0.24
|
9.41 score on a scale
Standard Error 0.12
|
|
PainOUT Scale Questions
Satisfaction with results of pain management treatment POD7
|
9.22 score on a scale
Standard Error 0.24
|
9.36 score on a scale
Standard Error 0.14
|
|
PainOUT Scale Questions
Satisfaction with results of pain management treatment POD90
|
9.07 score on a scale
Standard Error 0.23
|
9.32 score on a scale
Standard Error 0.25
|
|
PainOUT Scale Questions
Pain severity POD1
|
6.86 score on a scale
Standard Error 0.30
|
6.76 score on a scale
Standard Error 0.28
|
|
PainOUT Scale Questions
Pain severity POD2
|
6.84 score on a scale
Standard Error 0.30
|
6.90 score on a scale
Standard Error 0.29
|
|
PainOUT Scale Questions
Pain severity POD7
|
6.94 score on a scale
Standard Error 0.31
|
7.10 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Pain severity POD90
|
7.26 score on a scale
Standard Error 0.32
|
7.36 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Pain severity POD180
|
7.20 score on a scale
Standard Error 0.31
|
7.29 score on a scale
Standard Error 0.30
|
|
PainOUT Scale Questions
Pain relief POD2
|
9.80 score on a scale
Standard Error 0.32
|
9.90 score on a scale
Standard Error 0.26
|
|
PainOUT Scale Questions
Pain relief POD7
|
10.38 score on a scale
Standard Error 0.18
|
9.89 score on a scale
Standard Error 0.31
|
|
PainOUT Scale Questions
Pain relief POD90
|
9.19 score on a scale
Standard Error 0.52
|
10.35 score on a scale
Standard Error 0.30
|
|
PainOUT Scale Questions
Pain relief POD180
|
9.30 score on a scale
Standard Error 0.58
|
8.73 score on a scale
Standard Error 0.64
|
|
PainOUT Scale Questions
Time with severe pain POD1
|
2.83 score on a scale
Standard Error 0.26
|
2.72 score on a scale
Standard Error 0.24
|
|
PainOUT Scale Questions
Time with severe pain POD2
|
4.39 score on a scale
Standard Error 0.38
|
4.34 score on a scale
Standard Error 0.33
|
|
PainOUT Scale Questions
Time with severe pain POD7
|
3.28 score on a scale
Standard Error 0.29
|
3.67 score on a scale
Standard Error 0.36
|
|
PainOUT Scale Questions
Time with severe pain POD90
|
2.76 score on a scale
Standard Error 0.41
|
1.85 score on a scale
Standard Error 0.22
|
|
PainOUT Scale Questions
Time with severe pain POD180
|
1.57 score on a scale
Standard Error 0.21
|
2.18 score on a scale
Standard Error 0.38
|
SECONDARY outcome
Timeframe: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative dischargePopulation: Participants were lost to follow up/withdrawn.
The following questions used a scale of Yes/No, reporting number of patients with Yes * Been out of bed since surgery * Would have liked more pain treatment * Received information about pain treatment * Used non-medicine methods to relieve pain * Persistent painful condition for 3 months or more
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
PainOut Count Questions
Would have liked more pain treatment : POD90
|
9 Participants
|
8 Participants
|
|
PainOut Count Questions
Used non-medicine methods to relieve pain : POD2
|
50 Participants
|
47 Participants
|
|
PainOut Count Questions
Used non-medicine methods to relieve pain : POD7
|
48 Participants
|
48 Participants
|
|
PainOut Count Questions
Would have liked more pain treatment : POD1
|
9 Participants
|
13 Participants
|
|
PainOut Count Questions
Would have liked more pain treatment : POD2
|
5 Participants
|
6 Participants
|
|
PainOut Count Questions
Would have liked more pain treatment : POD7
|
8 Participants
|
10 Participants
|
|
PainOut Count Questions
Been out of bed since surgery : POD1
|
44 Participants
|
50 Participants
|
|
PainOut Count Questions
Been out of bed since surgery : POD2
|
50 Participants
|
48 Participants
|
|
PainOut Count Questions
Been out of bed since surgery : POD7
|
48 Participants
|
47 Participants
|
|
PainOut Count Questions
Been out of bed since surgery : POD90
|
41 Participants
|
45 Participants
|
|
PainOut Count Questions
Been out of bed since surgery : POD180
|
34 Participants
|
34 Participants
|
|
PainOut Count Questions
Would have liked more pain treatment : POD180
|
5 Participants
|
8 Participants
|
|
PainOut Count Questions
Received information about pain treatment : POD1
|
47 Participants
|
51 Participants
|
|
PainOut Count Questions
Used non-medicine methods to relieve pain : POD90
|
41 Participants
|
43 Participants
|
|
PainOut Count Questions
Received information about pain treatment : POD2
|
45 Participants
|
48 Participants
|
|
PainOut Count Questions
Received information about pain treatment : POD7
|
45 Participants
|
49 Participants
|
|
PainOut Count Questions
Received information about pain treatment : POD90
|
41 Participants
|
42 Participants
|
|
PainOut Count Questions
Received information about pain treatment : POD180
|
32 Participants
|
34 Participants
|
|
PainOut Count Questions
Used non-medicine methods to relieve pain : POD1
|
50 Participants
|
50 Participants
|
|
PainOut Count Questions
Used non-medicine methods to relieve pain : POD180
|
32 Participants
|
36 Participants
|
|
PainOut Count Questions
Persistent painful condition for 3 months or more : POD1
|
50 Participants
|
48 Participants
|
|
PainOut Count Questions
Persistent painful condition for 3 months or more : POD2
|
50 Participants
|
51 Participants
|
|
PainOut Count Questions
Persistent painful condition for 3 months or more : POD7
|
50 Participants
|
49 Participants
|
|
PainOut Count Questions
Persistent painful condition for 3 months or more : POD90
|
33 Participants
|
35 Participants
|
|
PainOut Count Questions
Persistent painful condition for 3 months or more : POD180
|
14 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 24 hours post operative discharge, 48 hours post operative discharge, 7days post operative discharge, 3 months post operative discharge, 6 months post operative dischargePopulation: Participants were lost to follow up/withdrawn.
DN4 questionnaire to assess neuropathic pain on postoperative day (POD)1, 2, 7, 90 and 180. The DN4 questionnaire is a series of Yes or No questions that revolves around the characteristics that may suggest the presence or development of neuropathic conditions/pain (burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching, hypoesthesia to touch, hypoesthesia to pinprick, pain increased by brushing). Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain.
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
DN4 Score
POD1
|
0.43 score on a scale
Standard Error 0.11
|
0.32 score on a scale
Standard Error 0.10
|
|
DN4 Score
POD2
|
0.72 score on a scale
Standard Error 0.13
|
0.56 score on a scale
Standard Error 0.12
|
|
DN4 Score
POD7
|
1.39 score on a scale
Standard Error 0.19
|
0.65 score on a scale
Standard Error 0.14
|
|
DN4 Score
POD90
|
0.84 score on a scale
Standard Error 0.15
|
0.61 score on a scale
Standard Error 0.12
|
|
DN4 Score
POD180
|
0.61 score on a scale
Standard Error 0.15
|
0.50 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 24 hours post operative discharge, 48 hours post operative dischargePopulation: Participants were lost to follow up/withdrawn.
The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions. The composite score will be reported for postoperative day (POD)1 and POD2. If a patient denies experiencing a particular symptom, their response will be coded as 0. If they do: Frequency will be assessed using a 4 point scale: 1. rarely 2. occasionally 3. frequently 4. almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1. slight 2. moderate 3. severe 4. very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1. not at all 2. a little bit 3. somewhat 4. quite a bit 5. very much with 1 being the lowest and 5 being the highest.
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Opioid-Related Symptom Distress (ORSDS) Scale
POD1
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Opioid-Related Symptom Distress (ORSDS) Scale
POD2
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: PACU, POD1, POD2, POD7Population: Participants were lost to follow up/withdrawn.
Patient consumption of non-opioid analgesics in the post-anesthesia care unit (PACU) and on postoperative day (POD)1, POD2, POD7. This was measured for acetaminophen, ibuprofen, ketorolac, meloxicam, naproxen, and gabapentin as yes/no. Number of participants who report "yes" for each non-opioid analgesic is reported.
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Non-opioid Analgesic Consumption
Ibuprofen : PACU
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Ibuprofen : POD1
|
3 Participants
|
2 Participants
|
|
Non-opioid Analgesic Consumption
Acetaminophen : PACU
|
42 Participants
|
42 Participants
|
|
Non-opioid Analgesic Consumption
Acetaminophen : POD1
|
51 Participants
|
51 Participants
|
|
Non-opioid Analgesic Consumption
Acetaminophen : POD2
|
46 Participants
|
44 Participants
|
|
Non-opioid Analgesic Consumption
Acetaminophen : POD7
|
46 Participants
|
48 Participants
|
|
Non-opioid Analgesic Consumption
Ibuprofen : POD2
|
2 Participants
|
1 Participants
|
|
Non-opioid Analgesic Consumption
Ibuprofen : POD7
|
3 Participants
|
2 Participants
|
|
Non-opioid Analgesic Consumption
Ketorolac : PACU
|
18 Participants
|
11 Participants
|
|
Non-opioid Analgesic Consumption
Ketorolac : POD1
|
45 Participants
|
44 Participants
|
|
Non-opioid Analgesic Consumption
Ketorolac : POD2
|
3 Participants
|
3 Participants
|
|
Non-opioid Analgesic Consumption
Ketorolac : POD7
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Meloxicam : PACU
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Meloxicam : POD1
|
10 Participants
|
6 Participants
|
|
Non-opioid Analgesic Consumption
Meloxicam : POD2
|
38 Participants
|
35 Participants
|
|
Non-opioid Analgesic Consumption
Meloxicam : POD7
|
36 Participants
|
36 Participants
|
|
Non-opioid Analgesic Consumption
Naproxen : PACU
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Naproxen : POD1
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Naproxen : POD2
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Naproxen : POD7
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Gabapentin : PACU
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Gabapentin : POD1
|
0 Participants
|
0 Participants
|
|
Non-opioid Analgesic Consumption
Gabapentin : POD2
|
0 Participants
|
1 Participants
|
|
Non-opioid Analgesic Consumption
Gabapentin : POD7
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)- 24 hours post operativePopulation: Participants were lost to follow up/withdrawn
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured during the first 24 hours postoperatively.
Outcome measures
| Measure |
Dronabinol
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Sleep Disturbance: Total Sleep Time
|
570 minutes
Interval 432.0 to 732.0
|
596 minutes
Interval 363.0 to 1024.0
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)- 24 hours post operativePopulation: Participants were lost to follow up/withdrawn.
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Wake After Sleep Onset is the duration of time a patient was awake after falling asleep and before getting out of bed. Measured during the first 24 hours postoperatively.
Outcome measures
| Measure |
Dronabinol
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Sleep Disturbance: Wake After Sleep Onset
|
75 minutes
Interval 54.0 to 87.0
|
64 minutes
Interval 44.5 to 92.5
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)- 24 hours post operativePopulation: Participants were lost to follow up/withdrawn.
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Sleep Efficiency is the ratio between total sleep time and the total time in bed. Measured during the first 24 hours postoperatively. Sleep Efficiency ratio is expressed as a percentage, where higher values represent better outcomes.
Outcome measures
| Measure |
Dronabinol
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Sleep Disturbance: Sleep Efficiency
|
88.2 percentage of sleep time
Interval 85.7 to 91.3
|
89 percentage of sleep time
Interval 86.1 to 91.1
|
SECONDARY outcome
Timeframe: Post operative day 0 (beginning in the PACU)- 24 hours post operativePopulation: Participants were lost to follow up/withdrawn.
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured as number of awakenings during the first 24 hours postoperatively.
Outcome measures
| Measure |
Dronabinol
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=49 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Sleep Disturbance: Number of Awakenings
|
23 awakening events
Interval 13.0 to 26.0
|
20 awakening events
Interval 14.5 to 26.0
|
SECONDARY outcome
Timeframe: PACU, Post-Op, POD1, POD2Population: Participants were lost to follow up/withdrawn.
Measured as yes/no for a series of 13 questions asking patients if they have experienced any: change of mood, difficulty with memory, slurring of speech, blurred vision, hallucinations, increased awareness of surroundings, palpitations, headache, dizziness, drowsiness, dry mouth, involuntary muscle twitching, or tremors. Number of participants who report "yes" for each symptom is reported. Measured in the post-anesthesia care unit (PACU), between PACU exist and midnight (Post-op), postoperative day (POD)1, POD2
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Cognitive Assessment
Post-Op : Tremors
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
POD1 : Blurred Vision
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
POD1 : Increased Awareness of Surroundings
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
PACU : Change of Mood
|
0 Participants
|
0 Participants
|
|
Cognitive Assessment
PACU : Difficulty with Memory
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
PACU : Slurring of Speech
|
2 Participants
|
2 Participants
|
|
Cognitive Assessment
PACU : Blurred Vision
|
0 Participants
|
1 Participants
|
|
Cognitive Assessment
PACU : Hallucinations
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
PACU : Increased Awareness of Surroundings
|
1 Participants
|
2 Participants
|
|
Cognitive Assessment
PACU : Palpitations
|
0 Participants
|
0 Participants
|
|
Cognitive Assessment
PACU : Headache
|
2 Participants
|
4 Participants
|
|
Cognitive Assessment
PACU : Dizziness
|
7 Participants
|
1 Participants
|
|
Cognitive Assessment
PACU : Drowsiness
|
21 Participants
|
18 Participants
|
|
Cognitive Assessment
PACU : Dry Mouth
|
41 Participants
|
35 Participants
|
|
Cognitive Assessment
PACU : Involuntary Muscle Twitching
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
PACU : Tremors
|
0 Participants
|
0 Participants
|
|
Cognitive Assessment
Post-Op : Change of Mood
|
3 Participants
|
0 Participants
|
|
Cognitive Assessment
Post-Op : Difficulty with Memory
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
Post-Op : Slurring of Speech
|
2 Participants
|
1 Participants
|
|
Cognitive Assessment
Post-Op : Blurred Vision
|
2 Participants
|
0 Participants
|
|
Cognitive Assessment
Post-Op : Hallucinations
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
Post-Op : Increased Awareness of Surroundings
|
0 Participants
|
1 Participants
|
|
Cognitive Assessment
Post-Op : Palpitations
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
Post-Op : Headache
|
6 Participants
|
1 Participants
|
|
Cognitive Assessment
Post-Op : Dizziness
|
7 Participants
|
2 Participants
|
|
Cognitive Assessment
Post-Op : Drowsiness
|
11 Participants
|
8 Participants
|
|
Cognitive Assessment
Post-Op : Dry Mouth
|
22 Participants
|
18 Participants
|
|
Cognitive Assessment
Post-Op : Involuntary Muscle Twitching
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
POD1 : Change of Mood
|
2 Participants
|
1 Participants
|
|
Cognitive Assessment
POD1 : Difficulty with Memory
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
POD1 : Slurring of Speech
|
0 Participants
|
2 Participants
|
|
Cognitive Assessment
POD1 : Hallucinations
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
POD1 : Palpitations
|
1 Participants
|
1 Participants
|
|
Cognitive Assessment
POD1 : Headache
|
7 Participants
|
2 Participants
|
|
Cognitive Assessment
POD1 : Dizziness
|
9 Participants
|
8 Participants
|
|
Cognitive Assessment
POD1 : Drowsiness
|
9 Participants
|
7 Participants
|
|
Cognitive Assessment
POD1 : Dry Mouth
|
18 Participants
|
13 Participants
|
|
Cognitive Assessment
POD1 : Involuntary Muscle Twitching
|
1 Participants
|
2 Participants
|
|
Cognitive Assessment
POD1 : Tremors
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Change of Mood
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Difficulty with Memory
|
1 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Slurring of Speech
|
0 Participants
|
1 Participants
|
|
Cognitive Assessment
POD2 : Blurred Vision
|
0 Participants
|
1 Participants
|
|
Cognitive Assessment
POD2 : Hallucinations
|
2 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Increased Awareness of Surroundings
|
0 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Palpitations
|
0 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Headache
|
4 Participants
|
0 Participants
|
|
Cognitive Assessment
POD2 : Dizziness
|
7 Participants
|
8 Participants
|
|
Cognitive Assessment
POD2 : Drowsiness
|
9 Participants
|
8 Participants
|
|
Cognitive Assessment
POD2 : Dry Mouth
|
10 Participants
|
10 Participants
|
|
Cognitive Assessment
POD2 : Involuntary Muscle Twitching
|
2 Participants
|
2 Participants
|
|
Cognitive Assessment
POD2 : Tremors
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: post-anesthesia care unit and postoperative day 1Population: Participants were lost to follow up/withdrawn.
Opioid consumption measured in morphine milligram equivalents in the post-anesthesia care unit and postoperative day 1 (analyzed as 0-24 hours after surgery)
Outcome measures
| Measure |
Dronabinol
n=55 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=56 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1
|
15 morphine milligram equivalents
Interval 7.5 to 20.0
|
15 morphine milligram equivalents
Interval 0.0 to 23.3
|
SECONDARY outcome
Timeframe: Postoperative Day 90Population: Participants were lost to follow up/withdrawn.
Number of participants reporting opioid use at postoperative day 90.
Outcome measures
| Measure |
Dronabinol
n=43 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Dronabinol 5mg Cap: Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
|
Placebo
n=47 Participants
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.
Placebo oral tablet: Non-active placebo
|
|---|---|---|
|
Opioid Consumption at Postoperative Day 90
|
0 Participants
|
2 Participants
|
Adverse Events
Dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place