Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Brugmann University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Total morphine consumption
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
S Group
Patients receiving sufentanil during induction of general anesthesia
Intervention: Sufentanil Citrate (Drug)
M Group
Patients receiving methadone during induction of general anesthesia
Intervention: Methadone Hydrochloride (Drug)
Outcomes
Primary Outcomes
Total morphine consumption
Time Frame: 72 hours
Total morphine consumption
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
- Patient satisfaction(72 hours)
Investigators
Tatiana Besse-Hammer
Head Physician of the Clinical Research Unit
Brugmann University Hospital