Using methadone to prevent pain after orthopedic surgery
Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
PHASE3 · Brugmann University Hospital · NCT05831345
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
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Brugmann University Hospital (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05831345 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 undergoing elective hip or knee arthroplasty with ASA status 1-3.
Not a fit: Patients with preoperative renal failure, significant hepatic dysfunction, or a history of opioid abuse may not benefit from this study.
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 performed: Previous studies have shown promising results with methadone for pain management, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (RECRUITING)
Study contacts
- Study coordinator: Riccardo Mora, MD
- Email: riccardo.mora@chu-brugmann.be
- Phone: 00393292199132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orthopedic Surgery