Intraoperative Methadone for the Prevention of Postoperative Pain

NCT ID: NCT05831345

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

S Group

Patients receiving sufentanil during induction of general anesthesia

Group Type: ACTIVE_COMPARATOR

Sufentanil Citrate

Intervention Type: 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

Patients receiving methadone during induction of general anesthesia

Group Type: EXPERIMENTAL

Methadone Hydrochloride

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tatiana Besse-Hammer

Head Physician of the Clinical Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Brugmann

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Riccardo Mora, MD

Role: CONTACT

riccardo.mora@chu-brugmann.be

00393292199132

Facility Contacts

Riccardo Mora, MD

Role: primary

riccardo.mora@chu-brugmann.be

00393292199132

Other Identifiers

CHUB-Methadone

Identifier Type: -

Identifier Source: org_study_id