CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Preoperative Methadone +1 moredrug
Likely dose
Preoperative Methadone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06691633
NCT06691633Phase 4Completed

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study

University of Louisville·interventional·Posted Nov 15, 2024·Updated Nov 15, 2024

In Brief

A Phase 4 clinical trial evaluating Preoperative Methadone and Preoperative Oxycodone for Osteoarthritis (OA) of the Knee. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA. The main questions it aims to answer are: * What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty? * Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty Participants will: * be randomized into one of two groups * undergo a primary TKA * complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedNov 15, 2024
Enrollment StartFeb 19, 2024
Primary CompletionSep 24, 2024
Study CompletionOct 18, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 1.6 years ago

Interventions

Preoperative Methadonedrug

patient receives a one-time preoperative dose of 10 mg of methadone

Preoperative Oxycodonedrug

patient receives a one-time preoperative dose of 10 mg of oral oxycodone