Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT05831345

Intraoperative Methadone for the Prevention of Postoperative Pain

Led by Brugmann University Hospital · Updated on 2025-02-07

80

Participants Needed

1

Research Sites

143 weeks

Total Duration

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AI-Summary

What this Trial Is About

The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively. Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed. It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient. Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.

CONDITIONS

Official Title

Intraoperative Methadone for the Prevention of Postoperative Pain

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • ASA physical status classification of 1 to 3
  • Scheduled for elective partial or total hip or knee arthroplasty
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Preoperative kidney failure (serum creatinine > 2 mg/dL or a 1.5-fold increase in baseline creatinine or GFR < 90 ml/min/1.73m2)
  • Significant liver dysfunction (prothrombin time < 50% or threefold increase in liver transaminases)
  • Known heart failure
  • Preoperative hemodynamic instability requiring inotropes or vasopressors
  • Known allergy to methadone or sufentanil
  • Preoperative opioid use or history of opioid abuse
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Brugmann

Brussels, Belgium, 1020

Actively Recruiting

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Research Team

R

Riccardo Mora, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Intraoperative Methadone for the Prevention of Postoperative Pain | DecenTrialz