Trial Outcomes & Findings for Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients (NCT NCT03236155)

NCT ID: NCT03236155

Last Updated: 2023-07-20

Results Overview

Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

304 participants

Primary outcome timeframe

30 days

Results posted on

2023-07-20

Participant Flow

Participant milestones

Participant milestones
Measure
1 Prescription
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
3 Prescriptions
Receives 30 pill prescription at discharge from hospital. Two refills available if requested. opioid pain pills: patient will receive their pain pill prescription
Overall Study
STARTED
143
161
Overall Study
COMPLETED
143
161
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1 Prescription
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
3 Prescriptions
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available if requested. opioid pain pills: patient will receive their pain pill prescription
Total
n=304 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=143 Participants
0 Participants
n=161 Participants
0 Participants
n=304 Participants
Age, Categorical
Between 18 and 65 years
70 Participants
n=143 Participants
83 Participants
n=161 Participants
153 Participants
n=304 Participants
Age, Categorical
>=65 years
73 Participants
n=143 Participants
78 Participants
n=161 Participants
151 Participants
n=304 Participants
Sex: Female, Male
Female
75 Participants
n=143 Participants
89 Participants
n=161 Participants
164 Participants
n=304 Participants
Sex: Female, Male
Male
68 Participants
n=143 Participants
72 Participants
n=161 Participants
140 Participants
n=304 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
143 Participants
n=143 Participants
161 Participants
n=161 Participants
304 Participants
n=304 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Opioid naive patients undergoing THA or TKA between August 2017 and April 2018 and Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient

Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient
1089.7 Morphine Milligram Equivalents (MME)
Standard Deviation 536.4
777.1 Morphine Milligram Equivalents (MME)
Standard Deviation 414.2

SECONDARY outcome

Timeframe: 90 days post operative (higher values represent better functioning total hip or total knee replacements).

Population: Scores closer to 100 are considered better outcomes

Postoperative total hip and total knee arthroplasty patient reported outcomes at 90 days (All reported as scores on a scale, ranges below.). For hips: Hip Disability and Osteoarthritis Outcome Score Joint Replacement (Hoos Jr), for knees: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement, (Koos Jr), additionally, all will complete the Veterans Rand-12 outcome (VR-12). All outcomes, closer to 100 are better outcomes. HOOS, JR: Questions coded 0 - 4 points, none - extreme pain, scored by summing responses (range 0-24), convert to t-score. Answer ranges 0 - 100 (0 - total hip disability, 100 -perfect hip health). KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental/physical, measure in standard deviations out of 100 points, where a score of 100 shows a patient's health functioning physically and mentally at their their best, zero represents a worse outcome.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018
Postop Koos Jr
65.9 score on a scale
Standard Deviation 9.9
65.0 score on a scale
Standard Deviation 11.7
Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018
Postop Hoos Jr
73.5 score on a scale
Standard Deviation 13.8
73.7 score on a scale
Standard Deviation 12.3
Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018
Postop VR-12
93.2 score on a scale
Standard Deviation 14.7
92.1 score on a scale
Standard Deviation 14.3

SECONDARY outcome

Timeframe: 90 days from time of surgery

Population: 304 opioid naive patients undergoing total hip or total knee arthroplasties

Complications will be recorded as follows post-operatively for 90 days following surgery; any patient that has a DVT/Pulmonary embolism, any return to the operating room within 90-days, any re-admission to the hospital within 90-days, Any report of superficial infection, any report of deep infection, a periprosthetic fracture of the joint replaced, cerebrovascular accident or transient ischemic attack, report of dislocation, or patients who report opioid withdrawal.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Complications
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 90 days

This will be done as monitored through the Illinois prescription monitoring program, collecting data on each patient enrolled to be sure that patients do not receive additional narcotic prescriptions beyond what is provided to them as part of the study.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Compliance
143 Number of Compliant Participants
161 Number of Compliant Participants

SECONDARY outcome

Timeframe: 10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).

Utilizing Preop Koos Jr, Preop Hoos Jr, and Pre operative VR-12, all subjects will be asked to provide a pre-operative patient reported outcome to compare to post-operative patient reported outcomes. All reported as scores on a scale, ranges below. HOOS, JR: Questions coded 0 to 4 points, none to extreme pain, scored by summing responses (range of 0-24), convert to interval score ranges 0 to 100 (0 - total hip disability, 100 -perfect hip health). KOOS, Jr: Same but for Knees VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Preoperative Patient Reported Outcomes
Preop Koos Jr
49.3 score on a scale
Standard Deviation 12.5
51.5 score on a scale
Standard Deviation 13.6
Preoperative Patient Reported Outcomes
Preop Hoos Jr
53.2 score on a scale
Standard Deviation 16.3
50.7 score on a scale
Standard Deviation 15.9
Preoperative Patient Reported Outcomes
Preop VR-12
90.8 score on a scale
Standard Deviation 14.6
89.1 score on a scale
Standard Deviation 16.1

SECONDARY outcome

Timeframe: Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery

Population: 304 opioid naïve patients undergoing THA or TKA, assessed daily from time of surgery to discharge from hospital (1 days - 4 weeks), Reported at 1-3 days, 1 week after surgery, 2 weeks after surgery, and 3-4 weeks after surgery (dependent on follow up appointment).

Utilizing the defense \& veterans pain rating scale, patients enrolled will be asked at multiple time points after surgery regarding their pain. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Postoperative Outpatient Pain Scores
Days 1-3 after discharge
4.0 score on a scale
Interval 0.0 to 10.0
4.3 score on a scale
Interval 0.0 to 8.3
Postoperative Outpatient Pain Scores
Week 1 after discharge
3.9 score on a scale
Interval 0.4 to 10.0
4.1 score on a scale
Interval 0.3 to 7.7
Postoperative Outpatient Pain Scores
Week 2 after discharge
3.3 score on a scale
Interval 0.0 to 9.6
3.1 score on a scale
Interval 0.0 to 7.6
Postoperative Outpatient Pain Scores
Weeks 3-4 after discharge
2.2 score on a scale
Interval 0.0 to 8.4
2.2 score on a scale
Interval 0.0 to 6.3

SECONDARY outcome

Timeframe: from time of surgery to discharge from hospital (1 day - 2 weeks)

Population: 304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018

Using the primary outcome of number of opioids taken by the patients while inpatient, those will be converted into morphine equivalents. This was obtained from the hospital chart during the patient's inpatient stay.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Postoperative Inpatient Opioid Utilization
64.6 Morphine Equivalent while inpatient
Standard Deviation 38.9
72.2 Morphine Equivalent while inpatient
Standard Deviation 55.9

SECONDARY outcome

Timeframe: assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported

Population: 304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018

Using a Defense and Veterans Pain Rating scale, patients were asked from date of surgery to the date of discharge for daily inpatient pain scores. This is a pain assessment tool, using numerical rating scale, 0 (no pain), 1, 2, and 3 (mild), 4, 5, and 6 (moderate), 7, 8, and 9 (severe) to 10 (worst pain possible). The higher the score, the more pain.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Postoperative Inpatient Pain Scores
4 score on a scale
Interval 0.0 to 8.7
4.5 score on a scale
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 90 days

304 opioid naïve patients undergoing THA or TKA between August 2017 and April 2018, reporting number of pills not used Illinois prescription monitoring program- utilized to confirm no other physician prescribed opiates to the participating patients. They were asked at each visit regarding unused medications and brought to the office to properly dispose.

Outcome measures

Outcome measures
Measure
90 (5mg OxyIR) Pills Prescribed
n=143 Participants
Receives 90 pills in single prescription at discharge from hospital opioid pain pills: patient will receive their pain pill prescription
30 (5mg OxyIR) Pills Prescribed
n=161 Participants
Receives 30 pill prescription at discharge from hospital. Two refills available
Number of Tablets Received From Pharmacy That Went Unused
73 Unused pills
Interval 0.0 to 90.0
15 Unused pills
Interval 0.0 to 30.0

Adverse Events

90 (5mg OxyIR) Pills Prescribed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

30 (5mg OxyIR) Pills Prescribed

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

Anne DeBenedetti, CRC

Rush University Medical Center

Phone: 3124322468

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place