Intraoperative methadone in orthopedic surgery.

Intraoperative methadone for the prevention of postoperative pain: a randomized, double-blind clinical study in orthopedic surgery.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000172-36-BE

Enrollment

Registered

2023-01-30

Start date

2023-02-28

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic surgery MedDRA version: 23.1 Level: LLT Classification code 10051079 Term: Orthopedic procedure System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: MEPHENON Pharmaceutical Form: Solution for injection INN or Proposed INN: Methadone hydrochloride CAS Number: 1095-90-5 Other descriptive name: Methadone hydrochloride Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years old ASA 1-3 status Elective partial or total hip and knee arthroplasty Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Patient refusal Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold increase in basal plasma creatinine or GFR < 50 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 Treatment with beta blockers and HR < 60 bpm Treatment with antidepressants

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical trial is to determine the effects of methadone on analgesic requirements and pain scales in the first 24 hours after orthopedic surgery without locoregional anesthesia, compared to patients receiving standard doses of sufentanil.;Secondary Objective: The secondary objective is greater satisfaction of patients receiving methadone in their pain management in the three postoperative days, compared to those receiving sufentanil, without an increase in complications and side effects.;Primary end point(s): Postoperative pain will be assessed by nurses in the recovery room and inpatient unit: total morphine consumption is noted and postoperative pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 to 10) at rest and during coughing at 11 different intervals. The level of sedation is also measured using a 5-point scale (Rudkin scale) and episodes of nausea and vomiting, side effects and complications are also encoded.;Timepoint(s) of evaluation of this end point: T0 = arrival in the recovery room T1 = 1 hour postoperative T2 = 2 hours postoperative T3 = 4 hours postoperative T4 = 8 hours postoperative T5 = 12 hours postoperative T6 = 18 hours postoperative T7 = 24 hours postoperative T8 = 48 hours postoperative T9 = 60 postoperative hours T10 = 72 hours postoperative (or before leaving the hospital department)	—

Measure

Time frame

Main Objective: The primary objective of this clinical trial is to determine the effects of methadone on analgesic requirements and pain scales in the first 24 hours after orthopedic surgery without locoregional anesthesia, compared to patients receiving standard doses of sufentanil.;Secondary Objective: The secondary objective is greater satisfaction of patients receiving methadone in their pain management in the three postoperative days, compared to those receiving sufentanil, without an increase in complications and side effects.;Primary end point(s): Postoperative pain will be assessed by nurses in the recovery room and inpatient unit: total morphine consumption is noted and postoperative pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 to 10) at rest and during coughing at 11 different intervals. The level of sedation is also measured using a 5-point scale (Rudkin scale) and episodes of nausea and vomiting, side effects and complications are also encoded.;Timepoint(s) of evaluation of this end point: T0 = arrival in the recovery room T1 = 1 hour postoperative T2 = 2 hours postoperative T3 = 4 hours postoperative T4 = 8 hours postoperative T5 = 12 hours postoperative T6 = 18 hours postoperative T7 = 24 hours postoperative T8 = 48 hours postoperative T9 = 60 postoperative hours T10 = 72 hours postoperative (or before leaving the hospital department)

—

Secondary

Measure	Time frame
Secondary end point(s): The pain is then evaluated during the three postoperative days thanks to the EVA but also via a general satisfaction questionnaire concerning the management of pain at the end of the stay. Side effects and complications are encoded.;Timepoint(s) of evaluation of this end point: During the three postoperative days.	—

Countries

Belgium

Contacts

Public ContactAnesthesiology Department

CHU Brugmann

seyedjavad.bidgoli@chu-brugmann.be3224772179

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026