Phase 4
N=304
Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03236155 ↗Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient — 1089.7; 777.1 Morphine Milligram Equivalents (MME)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- opioid pain pills (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient |
1089.7; 777.1 | — |
| SECONDARY Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018 |
65.9; 65.0; 73.5; 73.7; 93.2; 92.1 | — |
| SECONDARY Complications |
0; 0 | — |
| SECONDARY Compliance |
143; 161 | — |
| SECONDARY Preoperative Patient Reported Outcomes |
49.3; 51.5; 53.2; 50.7; 90.8; 89.1 | — |
| SECONDARY Postoperative Outpatient Pain Scores |
4.0; 4.3; 3.9; 4.1; 3.3; 3.1 | — |
| SECONDARY Postoperative Inpatient Opioid Utilization |
64.6; 72.2 | — |
| SECONDARY Postoperative Inpatient Pain Scores |
4; 4.5 | — |
| SECONDARY Number of Tablets Received From Pharmacy That Went Unused |
73; 15 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- any patient > 18 years of age scheduled for primary total hip or knee arthroplasty who is not consuming opioids during the 4 weeks prior to surgery
Exclusion Criteria
- patients consuming opioids during the 4 weeks prior to surgery
- patients who are allergic to oxycodone or refuse to take oxycodone
- patients with a history of opioid dependence or illegal or "off-label" opioid use
- patients undergoing a revision total knee or total hip arthroplasty
- any patient less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT03236155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.