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Intraoperative Methadone for the Prevention of Postoperative Pain

Primary Purpose

Orthopedic Surgery

Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Methadone Hydrochloride
Sufentanil Citrate
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Orthopedic Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU BrugmannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

S Group

M Group

Arm Description

Patients receiving sufentanil during induction of general anesthesia

Patients receiving methadone during induction of general anesthesia

Outcomes

Primary Outcome Measures

Total morphine consumption
Total morphine consumption
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))

Secondary Outcome Measures

Patient satisfaction
Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay

Full Information

First Posted
April 14, 2023
Last Updated
April 25, 2023
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05831345
Brief Title
Intraoperative Methadone for the Prevention of Postoperative Pain
Official Title
Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S Group
Arm Type
Active Comparator
Arm Description
Patients receiving sufentanil during induction of general anesthesia
Arm Title
M Group
Arm Type
Experimental
Arm Description
Patients receiving methadone during induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Methadone Hydrochloride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sufentanil Citrate
Intervention Description
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
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Total morphine consumption
Time Frame
72 hours
Title
Standard visual analogue scale (VAS)
Description
Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Mora, MD
Phone
00393292199132
Email
riccardo.mora@chu-brugmann.be
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Mora, MD
Phone
00393292199132
Email
riccardo.mora@chu-brugmann.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraoperative Methadone for the Prevention of Postoperative Pain

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