Intraoperative Methadone for the Prevention of Postoperative Pain

Phase 3

Recruiting

• Conditions: Orthopedic Surgery
• Interventions: Drug: Sufentanil Citrate; Drug: Methadone Hydrochloride

• Registration Number: NCT05831345
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S Group	Sufentanil Citrate	Patients receiving sufentanil during induction of general anesthesia
M Group	Methadone Hydrochloride	Patients receiving methadone during induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	72 hours	Total morphine consumption
Standard visual analogue scale (VAS)	24 hours	Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	72 hours	Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium