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Study on Methadone and Sufentanil for Pain Management After Orthopedic Surgery in Patients Without Locoregional Anesthesia

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing orthopedic surgery, specifically those having hip or knee replacement procedures. The study is investigating the use of methadone, a medication commonly used for pain relief, to see how it affects pain management after surgery. The trial compares methadone to another pain medication called sufentanil, which is typically used during surgery to manage pain.

The purpose of the study is to determine how methadone affects the need for additional pain medication and the level of pain experienced in the first 24 hours after surgery. Participants will receive either methadone or sufentanil during their surgery, and their pain levels will be monitored closely. Nurses will assess pain using a standard scale and will also note the amount of additional pain medication, like morphine, that is needed. The study will also track any side effects, such as nausea or sedation, that may occur.

After surgery, pain will continue to be evaluated over the next three days. Participants will be asked about their overall satisfaction with pain management during their hospital stay. This information will help researchers understand the effectiveness of methadone in managing postoperative pain compared to the standard treatment with sufentanil.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age between 18 and 80 years, ASA status 1-3, and undergoing elective partial or total hip and knee arthroplasty.

  2. Step 2

    Pre-surgery preparation

    Before surgery, information about the trial medications is provided. The medications used in the study are methadone hydrochloride and sufentanil, both administered as a solution for injection.

  3. Step 3

    Surgery and medication administration

    During the surgery, either methadone or sufentanil is administered. The specific dosage and frequency are determined by the medical team based on the study protocol.

  4. Step 4

    Postoperative pain assessment

    After surgery, pain levels are assessed using a visual analogue scale (VAS) ranging from 0 to 10, both at rest and during coughing, at 11 different intervals. Total morphine consumption is also recorded.

    The level of sedation is measured using a 5-point scale, and any episodes of nausea, vomiting, side effects, and complications are noted.

  5. Step 5

    Ongoing pain evaluation

    Pain is evaluated over the next three days using the VAS and a general satisfaction questionnaire regarding pain management. Side effects and complications continue to be recorded.

  6. Step 6

    End of study participation

    Participation in the study concludes after the postoperative evaluations and completion of the satisfaction questionnaire. The study is estimated to end by September 1, 2025.

Who can join the trial?

3 criteria

  • Age between 18 and 80 years old
  • ASA 1-3 status: This means the patient is classified as having a physical status of 1 to 3 according to the American Society of Anesthesiologists (ASA). This classification is used to assess the fitness of patients prior to surgery. ASA 1 is a normal healthy patient, ASA 2 is a patient with mild systemic disease, and ASA 3 is a patient with severe systemic disease.
  • Scheduled for elective partial or total hip and knee arthroplasty: This means the patient is planned to have a hip or knee replacement surgery that is not an emergency.

Who cannot join the trial?

5 criteria

  • Patients who have had **orthopedic surgery** with **locoregional anesthesia**. This means surgery on bones or muscles where a specific area of the body was numbed.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which may include groups like children, pregnant women, or those unable to give consent.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients with any medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Methadone

    is a medication used in this study to help manage pain after surgery. It is given during the operation to see if it can reduce the need for other pain medications and help control pain better in the first 24 hours after orthopedic surgery. Methadone works by changing the way the brain and nervous system respond to pain, which can help patients feel more comfortable after their surgery.

  • Sufentanil

    is another medication used in this study as a comparison to methadone. It is a strong pain reliever that is commonly used during surgeries to help manage pain. In this trial, patients receiving sufentanil will be compared to those receiving methadone to see which medication is more effective at reducing pain and the need for additional pain relief after surgery. Sufentanil works by binding to certain receptors in the brain to decrease the feeling of pain.

What is already known about the treatment

Methadone – Methadone is administered as an injection during surgery to help manage pain after the procedure. It is currently being studied in clinical trials to see how well it works for pain relief after orthopedic surgeries. The main use of methadone in this context is to reduce the need for other pain medications and to help control pain in the first 24 hours after surgery. Methadone works by affecting certain receptors in the brain and nervous system to decrease the feeling of pain. It is classified as an opioid analgesic, which means it is a type of medication used to relieve pain.

Investigated diseases

Orthopedic Surgery – Orthopedic surgery involves procedures that address issues related to the musculoskeletal system, which includes bones, joints, ligaments, tendons, and muscles. The progression of conditions requiring orthopedic surgery can vary widely, often involving degeneration, injury, or congenital abnormalities that affect movement and function. Over time, these conditions may lead to pain, reduced mobility, and impaired quality of life. Surgical intervention aims to correct deformities, repair injuries, or improve function. Post-surgery, patients typically experience a period of recovery that includes pain management and rehabilitation to restore strength and mobility.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518059-50-00Protocol codeCHUB-MethadoneEstimated enrolment80 patientsSponsorAssociation Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann

sourced from the EU Clinical Trials Register and site verification

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