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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Risk-benefit analysis of intrathecal morphine administration to patients undergoing surgical treatment of proximal femoral fracture (monocentric, single-blinded, randomized clinical study compared to standard treatment)

This study is investigating a new way to manage pain for people who have broken their hip bone and need surgery. It's looking at whether giving a dose of morphine directly into the spinal fluid during the operation provides better pain relief compared to the usual pain management methods. Researchers want to see if this special morphine dose can reduce pain more effectively, how much other painkillers are needed afterwards, and if it affects side effects like nausea or itching. This is a Phase III study, which means it's one of the final stages of testing, aiming to confirm if this treatment is better and safer for patients.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Fakultni Nemocnice Ostrava
Enrolment target
100
Start
31 Oct 2024

What is this study about?

This study is about making sure people who've broken their hip (often called a 'proximal femoral fracture') have the best possible pain relief during and after their surgery. A broken hip is a serious injury, and managing the pain effectively is very important for recovery. The study is comparing a specific way of giving a strong painkiller called morphine to the usual pain relief methods. Instead of just giving morphine through a drip or as a tablet, this study involves giving a small amount of morphine directly into the fluid around the spinal cord during the operation.

The main aim is to see if this method reduces pain more effectively than standard care. They'll be checking how much pain people feel both when they're resting and when they're moved, especially in the first 24 hours after surgery. The study also wants to find out if giving morphine this way means people need fewer other painkillers, how quickly they need more pain relief after surgery, and the total amount of strong painkillers (opioids) they use while in intensive care.

Researchers are also looking at other important things. They'll be monitoring for common side effects of strong painkillers, such as problems with breathing (hypoventilation), low blood pressure (hypotension), a slow heart rate (bradycardia), and feeling sick or vomiting after the operation. They'll also check for itching and how well any treatment for itching works. This detailed look helps them understand the full benefits and any potential downsides of this pain relief method.

Key takeaways

  • Tests a new way to give morphine for hip fracture pain.
  • Aims to improve pain relief after hip surgery.
  • Compares special morphine dose to standard pain care.
  • Measures pain, need for other painkillers, and side effects.
  • Open to adults aged 18 and over with a broken hip.

Who may be eligible?

This study is open to both men and women. To join, you need to be at least 18 years old – there's no upper age limit, so older adults are welcome to participate if they meet other criteria.

The most important requirement is that you have a broken hip bone that needs surgery. This study is specifically designed for people recovering from this type of injury and operation. Doctors will carefully review your health information to make sure joining the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a broken hip bone (proximal femoral fracture)?
  3. Are you scheduled for surgery for your broken hip?
  4. Are you able to understand and agree to take part in the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment (either the special morphine dose or standard pain relief) during your hip surgery. After the operation, you would be asked about your pain levels frequently for the first 24 hours, both when you're resting and when you're gently moved. Doctors and nurses will also keep track of how much other pain medication you need and monitor you closely for any side effects like feeling sick or itchy. We expect your main involvement in the study's specific checks to last about 24 hours after your surgery, during your recovery in the hospital.

Potential risks and benefits

Potential benefits could include better pain control after your hip surgery, possibly leading to a more comfortable recovery and less need for other painkillers. However, there are also potential risks related to giving morphine, such as feeling sick, itching, or, more rarely, effects on breathing or blood pressure, which will be closely monitored. You always have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Czechia

Common questions

What is a 'proximal femoral fracture'?

It's the medical term for a broken hip bone, specifically the upper part of the thigh bone near the hip joint.

What does 'intrathecal morphine' mean?

It means a small dose of morphine is given directly into the fluid surrounding your spinal cord during your surgery.

Will I know if I'm getting the special morphine or standard care?

Because this is a 'single-blinded' study, you won't know which treatment you receive, but your doctors will.

How long will the pain assessment last?

Your pain levels will be regularly checked for 24 hours after your surgery.

What if I feel sick or itchy after the treatment?

The study team will be carefully watching for these and other side effects, and they have treatments available to help manage them.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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