Trial Outcomes & Findings for The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy (NCT NCT04672252)
NCT ID: NCT04672252
Last Updated: 2023-03-07
Results Overview
Pain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Hour 24 Post-Surgery
Results posted on
2023-03-07
Participant Flow
Participant milestones
| Measure |
Cohort 1 - CBD
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
47
|
|
Overall Study
COMPLETED
|
52
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - CBD
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Baseline characteristics by cohort
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
57.65 years
STANDARD_DEVIATION 9.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
47 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Hour 24 Post-SurgeryPain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score
|
4.4 score on a scale
Standard Deviation 3.1
|
5.7 score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Day 2 Post-SurgeryPain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score
|
4.7 score on a scale
Standard Deviation 2.8
|
5.3 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Day 7 Post-SurgeryPain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score
|
2.5 score on a scale
Standard Deviation 1.9
|
3.2 score on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Day 14 Post-SurgeryPain severity scores at rest will be assessed by use of a visual analog scale (VAS; 0 = no pain, 10 = worst pain imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Pain Visual Analog Scale (VAS) Score
|
1.6 score on a scale
Standard Deviation 1.4
|
2.3 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Day 2 Post-SurgeryAny nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Nausea Score on VAS Scale
|
2.1 score on a scale
Standard Deviation 2.6
|
2.5 score on a scale
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: Day 7 Post-SurgeryAny nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Nausea Score on VAS Scale
|
0.2 score on a scale
Standard Deviation 1.1
|
0.6 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Day 14 Post-SurgeryAny nausea experienced by the patients will be recorded by use of a VAS (0 = no nausea, 10 = worst nausea imaginable).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Nausea Score on VAS Scale
|
0.1 score on a scale
Standard Deviation 0.4
|
0.5 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 1 Post-SurgeryConsumption based on patient-self-report
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Total Opioid Consumption
|
15.2 morphine milligram equivalent (MME)
Standard Deviation 12
|
19.7 morphine milligram equivalent (MME)
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Day 2 Post-SurgeryConsumption based on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Total Opioid Consumption
|
10.3 morphine milligram equivalent (MME)
Standard Deviation 18.7
|
16.7 morphine milligram equivalent (MME)
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: Day 7 Post-SurgeryConsumption based on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Total Opioid Consumption
|
59.3 morphine milligram equivalent (MME)
Standard Deviation 53.2
|
67.3 morphine milligram equivalent (MME)
Standard Deviation 55.2
|
SECONDARY outcome
Timeframe: Day 14 Post-SurgeryConsumption based on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Total Opioid Consumption
|
8 morphine milligram equivalent (MME)
Standard Deviation 19.3
|
10.3 morphine milligram equivalent (MME)
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Day 1 Post-SurgeryBased on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Number of Completed Doses Out of 3 Maximum Doses/Day
|
2.9 Doses
Standard Deviation 0.27
|
3 Doses
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 7 Post-SurgeryBased on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Number of Completed Doses Out of 3 Maximum Doses/Day
|
3 Doses
Standard Deviation 0
|
2.7 Doses
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Day 14 Post-SurgeryBased on patient-self-report.
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Number of Completed Doses Out of 3 Maximum Doses/Day
|
2.8 Doses
Standard Deviation 0.4
|
2.7 Doses
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Hour 24 Post-SurgeryPatients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Patient Satisfaction Score
|
7 score on a scale
Standard Deviation 3
|
5.6 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Day 2 Post-SurgeryPatients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Patient Satisfaction Score
|
7.3 score on a scale
Standard Deviation 2.5
|
6 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Day 7 Post-SurgeryPatients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Patient Satisfaction Score
|
8 score on a scale
Standard Deviation 2.6
|
7.9 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day 14 Post-SurgeryPatients will record their satisfaction with their management, on a 0-10 scale (where 0= not at all satisfied; and 10 = completely satisfied).
Outcome measures
| Measure |
Cohort 1 - CBD
n=52 Participants
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 Participants
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Patient Satisfaction Score
|
8.7 score on a scale
Standard Deviation 2.3
|
8.5 score on a scale
Standard Deviation 2.4
|
Adverse Events
Cohort 1 - CBD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 - Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 - CBD
n=52 participants at risk
CBD Oral Disintegrating Tablet (ODT): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
|
Cohort 2 - Placebo
n=47 participants at risk
Placebo ODT: Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
|
|---|---|---|
|
Hepatobiliary disorders
Elevated alanine transaminase
|
7.7%
4/52 • 2 weeks
Regular laboratory testing for elevated liver enzymes and self-reporting by participants.
|
8.5%
4/47 • 2 weeks
Regular laboratory testing for elevated liver enzymes and self-reporting by participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place