Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 80

Using methadone to prevent pain after orthopedic surgery

Official title: Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery

Run by Brugmann University Hospital · NCT05831345 · Data updated 2026-11-12

This study tests if giving methadone during orthopedic surgery can help manage pain better than sufentanil for patients having hip or knee replacements.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment80 (estimated)
SponsorBrugmann University Hospital
Academic / other
Locations1 site (Brussels)
StatusRecruiting
StartedFebruary 28, 2023
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedFebruary 7, 2025
Trial IDNCT05831345 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 undergoing elective hip or knee arthroplasty with ASA status 1-3.

Probably not a fit

Patients with preoperative renal failure, significant hepatic dysfunction, or a history of opioid abuse may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of intraoperative methadone administration for managing postoperative pain in patients undergoing orthopedic surgery, particularly when locoregional anesthesia is not feasible. The study compares methadone to sufentanil, focusing on pain control during the first 24 hours after surgery. It aims to determine if methadone's long half-life can provide superior pain relief without increasing adverse effects. The trial includes patients aged 18 to 80 undergoing elective hip or knee arthroplasty.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management for patients unable to receive locoregional anesthesia.

How similar studies have gone: Previous studies have shown promising results with methadone for pain management, suggesting this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age between 18 and 80 years old
* ASA 1-3 status
* Elective partial or total hip and knee arthroplasty

Exclusion Criteria:

* Patient refusal
* Preoperative renal failure (serum creatinine \> 2 mg/dL or 1.5-fold
* Increase in basal plasma creatinine or GFR \< 90 ml/min/1.73m2)
* Significant hepatic dysfunction (PT \<50% or increase in 3 times basal transaminases)
* Known heart failure
* Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
* Known methadone or sufentanil allergy
* Preoperative opioid use or history of opioid abuse
* Pregnancy and breastfeeding.

Where it's running

  • CHU Brugmann
    Brussels, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.