Intraoperative Methadone for the Prevention of Postoperative Pain

Orthopedic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831345
• Other study ID #: CHUB-Methadone
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Brugmann University Hospital
• Contact: Riccardo Mora, MD
• Phone: 00393292199132
• Email: riccardo.mora[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthopedic Surgery
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Total morphine consumption	72 hours
Primary	Standard visual analogue scale (VAS)	Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))	24 hours
Secondary	Patient satisfaction	Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay	72 hours