Intraoperative Methadone for the Prevention of Postoperative Pain

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrugmann University Hospital

About this trial

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

Qualifiers

Age between 18 and 80 years old

ASA 1-3 status

Elective partial or total hip and knee arthroplasty

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Methadone Hydrochloride
  • Sufentanil Citrate

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators