Clinical trial • Phase III • Musculoskeletal

METHADONE HYDROCHLORIDE for Orthopedic surgery | Total hip arthroplasty | Total knee arthroplasty

Phase III trial of METHADONE HYDROCHLORIDE for Orthopedic surgery | Total hip arthroplasty | Total knee arthroplasty.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Orthopedic surgery | Total hip arthroplasty | Total knee arthroplasty
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-11-2024
First CTIS Authorization Date
12-12-2024

Trial design

Randomised, sufenta (sufentanil) — comparator; route: injection; maximum total dose reported in record: 20 µg (doseuom: µg, maxtotaldoseamount: 20). detailed dosing schedule not specified in the available record.-controlled Phase III trial across 1 site in Belgium.

Randomised
Yes
Comparator
Sufenta (sufentanil) — comparator; route: injection; maximum total dose reported in record: 20 µg (doseUom: µg, maxTotalDoseAmount: 20). Detailed dosing schedule not specified in the available record.
Target Sample Size
80
Trial Duration For Participant
3

Eligibility

Recruits 80 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information sheets and informed consent forms are provided (documents: L1_SIS FR redacted, L1_SIS NL redacted, L1_ICF FR, L1_ICF NL). No further details on assent or specific consent handling for vulnerable participants are provided in the available record..

Pregnancy Exclusion
Pregnancy and breastfeeding
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information sheets and informed consent forms are provided (documents: L1_SIS FR redacted, L1_SIS NL redacted, L1_ICF FR, L1_ICF NL). No further details on assent or specific consent handling for vulnerable participants are provided in the available record.

Inclusion criteria

  • {"criterion_text":"- Age between 18 and 80 years old\n- ASA 1-3 status\n- Elective partial or total hip and knee arthroplasty"}

Exclusion criteria

  • {"criterion_text":"- Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold increase in basal plasma creatinine or GFR < 50 ml/min/1.73m2)\n- Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)\n- Known heart failure\n- Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)\n- Known methadone or sufentanil allergy\n- Preoperative opioid use or history of opioid abuse\n- Pregnancy and breastfeeding\n- Treatment with beta blockers and HR < 60 bpm\n- Treatment with antidepressants"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Total morphine consumption recorded; postoperative pain measured using an 11-point visual analogue scale (VAS) at rest and during coughing at 11 intervals; sedation measured with a 5-point Rudkin scale; episodes of nausea/vomiting, side effects and complications recorded."}

Secondary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Pain evaluated during the three postoperative days using EVA (VAS) and a general satisfaction questionnaire at discharge; side effects and complications recorded."}

Recruitment

Planned Sample Size
80
Recruitment Window Months
39
Consent Approach
Informed consent obtained from participants. Subject information sheet and informed consent form available in French and Dutch (L1_SIS FR/NL and L1_ICF FR/NL). Participants are adults (age 18-80). No assent process or additional consent-by-proxy details are provided in the available record.

Geography

Total Number Of Sites
1
Total Number Of Participants
80

Belgium

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
440
Number Of Sites
1
Number Of Participants
80

Sites

Site Name
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Department Name
Anesthesiology
Principal Investigator Name
Seyed Javad BIDGOLI
Principal Investigator Email
SEYEDJAVAD.BIDGOLI@chu-brugmann.be
Contact Person Name
Seyed Javad BIDGOLI
Number Of Participants
80

Sponsor

Primary sponsor

Full Name
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
MEPHENON 10mg/1ml solution injectable
Active Substance
METHADONE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Authorised (marketing authorisation BE117327)
Maximum Dose
20 mg
Investigational Product Name
Sufenta
Active Substance
SUFENTANIL
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Authorised (marketing authorisation 13895)
Maximum Dose
20 µg

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