Orthopedic Surgery
Conditions
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.
Interventions
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
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
Sponsors
Brugmann University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 72 hours | Total morphine consumption |
| Standard visual analogue scale (VAS) | 24 hours | Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 72 hours | Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay |
Countries
Belgium
Contacts
Primary ContactRiccardo Mora, MD
Outcome results
None listed