RecruitingPhase 3NCT05831345

Intraoperative Methadone for the Prevention of Postoperative Pain

Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery


Sponsor

Brugmann University Hospital

Enrollment

80 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • 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.

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Interventions

DRUGMethadone 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

DRUGSufentanil 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


Locations(1)

CHU Brugmann

Brussels, Belgium

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NCT05831345


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