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NCT Number: NCT05831345

Intraoperative Methadone for the Prevention of Postoperative Pain

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.

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Key information

Conditions

Orthopedic Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methadone Hydrochloride

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

Sufentanil Citrate

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

Primary outcomes

  1. Total morphine consumption

    Time frame: 72 hours

    Total morphine consumption

  2. Standard visual analogue scale (VAS)

    Time frame: 24 hours

    Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))

Secondary outcomes

  1. Patient satisfaction

    Time frame: 72 hours

    Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Riccardo Mora, MD

CONTACT

[email protected]

00393292199132

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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