Intraoperative Methadone for the Prevention of Postoperative Pain

NCT05831345 | Recruiting Phase 3

• 1 other identifier: CHUB-Methadone
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient satisfaction

  72 hours

Study Arms (2)

S Group

ACTIVE COMPARATOR

Patients receiving sufentanil during induction of general anesthesia

Drug: Sufentanil Citrate

M Group

EXPERIMENTAL

Patients receiving methadone during induction of general anesthesia

Drug: Methadone Hydrochloride

Interventions

Methadone Hydrochloride DRUG

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

M Group

Sufentanil Citrate DRUG

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

S Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

MeSH Terms

Interventions

Methadone; Sufentanil

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Riccardo Mora, MD

CONTACT

00393292199132; riccardo.mora@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physician of the Clinical Research Unit

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: February 28, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)