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Study on Intrathecal Morphine for Pain Relief in Patients with Hip Fractures Undergoing Surgery

Verified siteRegistered 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 who have a proximal femur fracture, which is a type of hip fracture. The study is investigating the use of morphine, a medication commonly used to relieve pain. In this trial, morphine will be administered intrathecally, meaning it is injected into the space around the spinal cord, to see if it provides better pain relief compared to other methods of giving pain medication.

The purpose of the study is to determine if this method of administering morphine results in better pain management for patients undergoing surgery for a proximal femur fracture. Participants will be randomly assigned to receive either the intrathecal morphine or the standard pain treatment. The study will monitor various aspects of pain relief, such as how much pain the patients feel at rest and during movement, and how long it takes before they need additional pain medication.

Throughout the study, researchers will also keep track of any side effects, such as breathing difficulties, low blood pressure, slow heart rate, nausea, vomiting, and itching. The effectiveness of treatments for these side effects will also be evaluated. The study aims to provide valuable information on whether intrathecal morphine is a more effective pain management option for patients with hip fractures undergoing 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

    Upon joining the study, the patient must meet certain criteria, including being classified as ASA I to III, being indicated for a procedure in subarachnoid block, and having signed an informed consent form.

  2. Step 2

    Surgical procedure

    The patient undergoes surgical treatment for a proximal femur fracture. During this procedure, morphine is administered intrathecally, which means it is injected into the space around the spinal cord.

  3. Step 3

    Pain assessment

    Pain is assessed using a scale called VAS10, where 0 indicates no pain and 10 indicates the worst pain imaginable. This assessment is conducted at rest and while positioning the patient, every 2 hours for 24 hours.

  4. Step 4

    Monitoring and medication

    The time until the first administration of rescue medication, such as additional pain relief, is recorded. The total consumption of opioids and non-opioid pain relief in the intensive care unit over 24 hours is also monitored.

  5. Step 5

    Secondary monitoring

    The patient is monitored for potential side effects, including hypoventilation (slow breathing), hypotension (low blood pressure), bradycardia (slow heart rate), nausea, vomiting, and itching. The effectiveness of treatments for these side effects is also evaluated.

Who can join the trial?

6 criteria

  • The patient must have a **proximal femur fracture**. This means a break in the upper part of the thigh bone near the hip.
  • The patient must be classified as **ASA I - III**. This is a system used by doctors to describe a patient's overall health. ASA I means the patient is healthy, ASA II means the patient has a mild health issue, and ASA III means the patient has a more serious health issue but is not life-threatening.
  • The patient must be indicated for a procedure using a **subarachnoid block**. This is a type of anesthesia where medicine is injected near the spinal cord to numb the lower part of the body.
  • The patient must have signed an **informed consent form**. This means the patient has been given information about the study and agrees to participate.
  • The patient must be within the age range of **18 to 64 years old**.
  • Both **female and male** patients can participate.

Who cannot join the trial?

4 criteria

  • Patients who have a **proximal femur fracture** cannot participate. This means a break in the upper part of the thigh bone near the hip.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible.
  • Patients who do not meet the gender criteria for the study cannot participate. The study includes both male and female participants.
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Investigated drugs

Morphine is being studied for its use in pain management during surgery. In this trial, it is administered intrathecally, which means it is injected into the space around the spinal cord. This method is being tested to see if it provides better pain relief for patients undergoing surgery for a hip fracture compared to other ways of giving pain medication.

What is already known about the treatment

Morphine – Morphine is administered intrathecally, meaning it is injected into the spinal canal, specifically for managing pain in patients undergoing surgery for proximal femur fractures. Currently, it is being studied in clinical trials to assess its effectiveness compared to standard opioid treatments. The main therapeutic indication is pain relief, particularly in surgical settings. Morphine works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Proximal Femur Fracture – A proximal femur fracture refers to a break in the upper part of the thigh bone, near the hip joint. This type of fracture is common in older adults, often resulting from a fall or direct impact to the hip area. The fracture can cause severe pain, swelling, and an inability to bear weight on the affected leg. As the condition progresses, it may lead to complications such as reduced mobility and muscle weakness. Healing typically requires immobilization and may involve surgical intervention to realign and stabilize the bone. Recovery can be prolonged, with rehabilitation needed to restore function and strength.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513996-42-00Estimated enrolment100 patientsSponsorFakultni Nemocnice Ostrava

sourced from the EU Clinical Trials Register and site verification

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