Intraoperative Methadone for the Prevention of Postoperative Pain

CHU Brugmann University Hospital

Status and phase: Enrolling; Phase 3

Conditions: Orthopedic Surgery

Treatments: Drug: Methadone Hydrochloride; Drug: Sufentanil Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05831345

CHUB-Methadone

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

S Group

Active Comparator group

Description:

Patients receiving sufentanil during induction of general anesthesia

Treatment:

Drug: Sufentanil Citrate

M Group

Experimental group

Description:

Patients receiving methadone during induction of general anesthesia

Treatment:

Drug: Methadone Hydrochloride