Intraoperative Methadone for the Prevention of Postoperative Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Surgery
• Intervention / Treatment: Drug: Sufentanil Citrate; Drug: Methadone Hydrochloride

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Riccardo Mora, MD; Phone Number: 00393292199132; Email: riccardo.mora@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: Riccardo Mora, MD; Phone Number: 00393292199132; Email: riccardo.mora@chu-brugmann.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: S Group; Patients receiving sufentanil during induction of general anesthesia	Drug: Sufentanil Citrate; Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy
Experimental: M Group; Patients receiving methadone during induction of general anesthesia	Drug: Methadone Hydrochloride; Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay	72 hours

Collaborators and Investigators

• Sponsor: Brugmann University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Respiratory System Agents; Antitussive Agents; Dsuvia; Methadone; Sufentanil
• Other Study ID Numbers: CHUB-Methadone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No