NCT03236155

Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients

Completed Phase 4 Results posted Last updated 20 July 2023

What this trial tests

Phase 4 trial testing opioid pain pills in Postoperative Pain in 304 participants. Completed in 26 August 2018.

Timeline

1 July 2017

Primary endpoint
1 July 2018

26 August 2018

Quick facts

Lead sponsor	Rush University Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	304
Start date	1 July 2017
Primary completion	1 July 2018
Estimated completion	26 August 2018
Sites	1 location across United States

Drugs / interventions tested

• opioid pain pills — full drug profile →

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient Primary · 30 days

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.

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	1089.7	± 536.4
30 (5mg OxyIR) Pills Prescribed	777.1	± 414.2

Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018 Secondary · 90 days post operative (higher values represent better functioning total hip or total knee replacements).

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 disab

Postop Koos Jr

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	65.9	± 9.9
30 (5mg OxyIR) Pills Prescribed	65.0	± 11.7

Postop Hoos Jr

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	73.5	± 13.8
30 (5mg OxyIR) Pills Prescribed	73.7	± 12.3

Postop VR-12

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	93.2	± 14.7
30 (5mg OxyIR) Pills Prescribed	92.1	± 14.3

Complications Secondary · 90 days from time of surgery

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.

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	0
30 (5mg OxyIR) Pills Prescribed	0

Compliance Secondary · 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.

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	143
30 (5mg OxyIR) Pills Prescribed	161

Preoperative Patient Reported Outcomes Secondary · 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

Preop Koos Jr

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	49.3	± 12.5
30 (5mg OxyIR) Pills Prescribed	51.5	± 13.6

Preop Hoos Jr

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	53.2	± 16.3
30 (5mg OxyIR) Pills Prescribed	50.7	± 15.9

Preop VR-12

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	90.8	± 14.6
30 (5mg OxyIR) Pills Prescribed	89.1	± 16.1

Postoperative Outpatient Pain Scores Secondary · Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery

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.

Days 1-3 after discharge

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	4.0	0 – 10
30 (5mg OxyIR) Pills Prescribed	4.3	0 – 8.3

Week 1 after discharge

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	3.9	0.4 – 10
30 (5mg OxyIR) Pills Prescribed	4.1	0.3 – 7.7

Week 2 after discharge

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	3.3	0 – 9.6
30 (5mg OxyIR) Pills Prescribed	3.1	0 – 7.6

Weeks 3-4 after discharge

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	2.2	0 – 8.4
30 (5mg OxyIR) Pills Prescribed	2.2	0 – 6.3

Postoperative Inpatient Opioid Utilization Secondary · from time of surgery to discharge from hospital (1 day - 2 weeks)

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.

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	64.6	± 38.9
30 (5 mg OxyIR) Pills Prescribed	72.2	± 55.9

Postoperative Inpatient Pain Scores Secondary · assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported

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.

Group	Value	95% CI
90 (5mg OxyIR) Prescribed	4	0 – 8.7
30 (5mg OxyIR) Prescribed	4.5	0 – 10

Number of Tablets Received From Pharmacy That Went Unused Secondary · 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.

Group	Value	95% CI
90 (5mg OxyIR) Pills Prescribed	73	0 – 90
30 (5mg OxyIR) Prescribed	15	0 – 30

Sponsor's own description

The United States constitutes \<5% of the world's population but over 80% of the opioid supply and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids. Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood of readmission for pain. Available data suggests that orthopaedic surgeons are the most likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are over 7 times more likely to come from an orthopaedic surgeon than another type of physician, but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many studies have investigated the utilization of opioids after surgery to assess surgeon's tendencies to overprescribe, demographics of those likely to overuse, and adverse events of opioid abusers.

The primary purpose of this randomized controlled trial is to determine whether prescribing fewer opioid pills per prescription reduces the total amount of opioids taken, even while allowing equal total opioid availability via increased frequency of prescription availability.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.