NCT07485803 Methadone in the Management of Post-Operative Pain in Total Knee Replacement
| NCT ID | NCT07485803 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | AdventHealth |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 192 participants in total. It began in 2026-06-01 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07485803 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07485803 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07485803 currently recruiting?
Yes, NCT07485803 is actively recruiting participants. Contact the research team at makenna.hemmerle@adventhealth.com for enrollment information.
Where is the NCT07485803 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT07485803 clinical trial?
NCT07485803 is sponsored by AdventHealth. The trial plans to enroll 192 participants.