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NCT06691633 · ClinicalTrials.gov registry record · Phase 4
Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA
A Phase 4 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT06691633: Completed Phase 4 study, sponsored by University of Louisville.
NCT06691633 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06691633, a Phase 4 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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
Primary Outcome
Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA
Interventions
- DRUG Preoperative Methadone
- DRUG Preoperative Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2024-10-18 |
| Phase | Phase 4 |
What the finished NCT06691633 record still lists
NCT06691633 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Preoperative Methadone is the first listed.
NCT06691633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06691633 about?
NCT06691633 is a clinical study titled "Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA". 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 ...
What is the current status of trial NCT06691633?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-02-19. Estimated completion is 2024-10-18.
What interventions are being tested in trial NCT06691633?
The interventions under investigation include: Preoperative Methadone (DRUG), Preoperative Oxycodone (DRUG).
Who is sponsoring clinical trial NCT06691633?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06691633's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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