Intraoperative Methadone for the Prevention of Postoperative Pain

Last updated: February 5, 2025
Sponsor: Brugmann University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Orthopedic Surgery

Orthopedics

Treatment

Sufentanil Citrate

Methadone Hydrochloride

Clinical Study ID

NCT05831345
CHUB-Methadone
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 80 years old

  • ASA 1-3 status

  • Elective partial or total hip and knee arthroplasty

Exclusion

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

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Sufentanil Citrate
Phase: 3
Study Start date:
February 28, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHU Brugmann

    Brussels, 1020
    Belgium

    Active - Recruiting

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