Intraoperative Methadone for the Prevention of Postoperative Pain
Recruiting
Phase 3
Interventional Study
Orthopedic Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 80 (estimated)
- Sponsor
- Brugmann University Hospital · Other
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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 va…
Trial Locations
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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…
Contacts