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Study on Methadone and Placebo for Pain Relief in Elderly Patients with Hip Fractures

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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 studying the effects of a medication called methadone in patients who have experienced a hip fracture. Hip fractures are breaks in the upper part of the thigh bone, often occurring in older adults. The trial aims to understand how a single dose of methadone, given during surgery, compares to a placebo in managing pain for these patients.

Participants in the study will receive either methadone or a placebo intravenously, which means the medication is delivered directly into a vein. The study will observe various aspects of recovery, such as the need for additional pain medication, the ability to stand and move, and any side effects like nausea or constipation. The goal is to see if methadone can effectively reduce pain and improve recovery after hip fracture surgery.

The trial is part of a larger research effort called the MetaHip trial and is expected to continue until 2025. By participating, researchers hope to gather valuable information that could improve pain management strategies for elderly patients undergoing hip fracture surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after being diagnosed with an acute hip fracture, confirmed by x-rays in the emergency department. Eligible patients are those aged 60 years or older.

  2. Step 2

    Preparation for surgery

    Before surgery, a single dose of methadone or a placebo is administered intravenously. Methadone is a medication used to manage pain. The placebo is a substance with no active medication, used for comparison.

  3. Step 3

    Surgery

    The surgical procedure for the hip fracture is performed. The focus is on managing pain effectively during this period.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring includes assessing daily consumption of pain medications, specifically opioids. Other factors observed are pain levels, ability to stand, mobility, nausea or vomiting, time to discharge, need for an antidote, delirium, and constipation.

  5. Step 5

    Follow-up

    Regular follow-ups are conducted to evaluate recovery progress and any side effects experienced. The trial aims to conclude by April 30, 2025.

Who can join the trial?

6 criteria

  • Patients must have a diagnosis of an acute hip fracture. This means the fracture happened less than 24 hours ago and was confirmed by x-rays in the emergency department.
  • The types of hip fractures included are:
    • Collum femoris fractures: A break in the neck of the thigh bone.
    • Pertrochanteric fractures: A break in the upper part of the thigh bone, near the hip joint.
    • Subtrochanteric fractures: A break just below the lesser trochanter, which is a small bump on the upper part of the thigh bone.
    • Participants must be 60 years of age or older.
    • Both male and female patients are eligible to participate.

Who cannot join the trial?

4 criteria

  • Patients who are not undergoing surgery for a hip fracture cannot participate. A hip fracture is a break in the upper part of the thigh bone near the hip joint.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for ensuring safety and accuracy in the study.
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Investigated drugs

Methadone is being studied in this trial to see if it can help reduce pain in elderly patients who have had hip fracture surgery. The trial is looking at the effects of giving a single dose of methadone during the surgery to see if it provides better pain relief compared to not receiving the medication.

What is already known about the treatment

Methadone – Methadone is administered orally or via injection and is currently being studied in clinical trials for its effectiveness in managing pain during hip fracture surgeries in elderly patients. It is well-documented in medical literature as a potent pain reliever, primarily used for severe pain management and opioid addiction treatment. The main therapeutic indication in this trial is to provide pain relief during surgery for hip fractures. Methadone works by binding to opioid receptors in the brain, altering the perception of pain. It is classified pharmacologically as an opioid analgesic.

Investigated diseases

Hip Fractures – Hip fractures are breaks in the upper part of the femur, commonly occurring in older adults due to falls or weakened bones. These fractures can cause severe pain and limit the ability to move or bear weight on the affected leg. The condition often requires surgical intervention to repair the fracture and restore mobility. Recovery can involve a lengthy rehabilitation process to regain strength and function. Hip fractures can lead to complications such as reduced mobility and increased dependency on others for daily activities.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase ITrial ID2023-506252-24-00Estimated enrolment130 patientsSponsorSygehus Soenderjylland Soenderborg

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