One preoperative dose of IV methadone for pain after knee replacement
Official title: A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement
Run by AdventHealth · NCT07485803 · Data updated 2026-11-12
This study tests whether a single IV methadone dose given before total knee replacement can improve postoperative pain control and reduce later pain medicine use for patients undergoing the surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Enrollment | 192 (estimated) |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | April 2028 |
| Study ends | June 2028 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07485803 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 21-75 undergoing unilateral total knee arthroplasty at AdventHealth Porter (Denver) who consent and are eligible after screening.
✕Probably not a fit
Patients who cannot receive spinal anesthesia or who do not tolerate the standard multimodal pain regimen may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 4 trial investigates whether administering one dose of IV methadone right before unilateral total knee arthroplasty improves postoperative pain management. All participants receive standard multimodal analgesia, including acetaminophen, gabapentin, and meloxicam, with methadone as the investigational addition. The study will compare postoperative pain scores and opioid requirements to typical recovery patterns, aiming to see if the preoperative methadone dose reduces overall analgesic needs. Eligible patients are adults aged 21 to 75 undergoing unilateral knee replacement at AdventHealth Porter in Denver and meeting safety criteria related to opioid exposure and substance use. The trial adheres to rigorous screening, consent, and follow-up procedures to assess safety and efficacy in a real-world setting.
Why it matters
Potential benefit: If successful, patients may experience better pain control after knee replacement and use less opioid medication during recovery.
How similar studies have gone: Previous research in related settings suggests methadone can influence postoperative pain, but results vary and this study adds contemporary, real-world data in a Phase 4 context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent from 2. Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study. 3. Age 21- 75 4. Unilateral total knee arthroplasty at Colorado Joint Replacement 5. All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Exclusion Criteria: 1. Narcotic use in the past 6 weeks 2. Current or previous history of drug and alcohol abuse 3. Tobacco use in the previous 90 days 4. Treatment with another investigational drug 5. Patients that cannot receive spinal anesthesia 6. Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)' 7. Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility 8. Obstructive sleep apnea 9. Morbid obesity (BMI \>40) 10. Patients with liver disease. 11. Significant kidney disease - stage 3 CKD or greater 12. Pregnant or nursing females 13. Baseline QTc \>480 14. severe COPD (GOLD 3 or 4) 15. home oxygen requirement
Where it's running
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AdventHealth Porter
Denver, Colorado, United States Recruiting
Study contacts
- Study coordinator: Makenna Hemmerle
- Email: makenna.hemmerle@adventhealth.com
- Phone: 303-260-2951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.