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Phase 4 N=304 Randomized Triple-blind Treatment

Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients

Postoperative Pain

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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