Intraoperative Methadone for the Prevention of Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methadone Hydrochloride, Sufentanil Citrate.
- Who it may be relevant to
- Registry conditions: Orthopedic Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
Overview
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.
Interventions
- Drug 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 - 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
Primary outcome measures
- Total morphine consumption [Time frame: 72 hours]
- Standard visual analogue scale (VAS) [Time frame: 24 hours]
Secondary outcome measures (1)
- Patient satisfaction [Time frame: 72 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Belgium · 1 center
- CHU Brugmann — Brussels
Identifiers
NCT: NCT05831345 · CHUB-Methadone