All studies
AuthorisedPhase III and phase IV (Integrated)Interventional

Comparison of low versus intermediate intravenous dexamethasone doses on rebound pain after ambulatory open foot surgery under popliteal sciatic nerve block: a double-blind clinical trial.

This research study is investigating how effective a medicine called dexamethasone is at preventing strong pain after minor foot surgery. Many people receive a numbing injection in their leg (called a popliteal sciatic nerve block) for this type of operation. Once this numbing wears off, some people experience a sharp increase in pain, known as 'rebound pain'. The study aims to compare two different doses of dexamethasone – a lower dose versus a medium dose – to see which one is better at reducing this rebound pain. Patients will be carefully monitored for their pain levels after surgery using a simple pain scale, and the information gathered will help doctors decide the best way to manage pain and improve recovery for future patients.

At a glance

Status
Authorised
Phase
Phase III and phase IV (Integrated)
Sponsor
Hospital Universitario Dr Peset Aleixandre
Enrolment target
180
Start
10 Dec 2025

What is this study about?

Imagine you're having a small operation on your foot. To make sure you don't feel anything during the surgery, doctors often give you a special numbing injection in your leg. This injection works really well, but once it starts to wear off, some people find that their pain suddenly becomes very strong – this is what doctors call 'rebound pain'.

This study is trying to find the best way to stop this rebound pain from happening. They are looking at a common medicine called dexamethasone. This medicine is often used to reduce swelling and pain. The researchers want to compare two different amounts, or 'doses', of dexamethasone to see which one works better to keep pain under control after your numbing injection wears off. They hope to find a way to make recovery smoother and more comfortable for patients.

To do this, they will ask patients to rate their pain using a simple scale from 0 (no pain) to 10 (the worst pain imaginable) after their surgery. By comparing pain scores in groups who received different doses of dexamethasone, the doctors can learn which dose is most effective at preventing this type of strong pain. They will also keep an eye on how quickly pain starts and any side effects from the medicine. This information is really important because it could help doctors all over the UK make better choices about pain relief for people having similar operations.

Key takeaways

  • Researchers are comparing two doses of dexamethasone to reduce 'rebound pain' after foot surgery.
  • The study focuses on pain that occurs after a leg numbing injection wears off.
  • Pain levels will be checked using a simple 0-10 scale via phone calls.
  • The aim is to find the best way to help patients have a more comfortable recovery.
  • You won't know which dose you're getting, ensuring fair and accurate results.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Essentially, if you're an adult scheduled for minor foot surgery where you'll receive a specific type of numbing injection in your leg (called a popliteal sciatic nerve block), you might be able to take part.

The research team will have a more detailed list of who can and cannot join, as certain health conditions or medications might mean the study isn't suitable for you. They will discuss all of this with you if you're interested.

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 of age or older?
  2. Are you scheduled for minor foot surgery?
  3. Will you be receiving a numbing injection in your leg (a popliteal sciatic nerve block) for your surgery?
  4. Are you able to participate in phone calls for follow-up?
  5. Are you able to understand and rate your pain using a simple scale?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect:

Before your surgery, you will receive instructions on how to use a simple pain scale, usually from 0 (no pain) to 10 (worst pain possible). During your surgery, you will receive the numbing injection in your leg, as planned for your operation, and you will also receive one of the study doses of dexamethasone. Neither you nor your doctors will know whether you received the lower or medium dose – this is called 'double-blind'.

After your surgery, once you're back home, the research team will call you at 24, 48, and 72 hours later. During these phone calls, they will ask you to rate your pain using the scale you were taught. They'll also ask when your pain started after the numbing injection wore off and check to see if you've had any unexpected or uncomfortable reactions to the medication. For about a month after your surgery, they will also monitor you for any issues with wound healing or infections. Your total participation will involve these phone check-ups for up to three days after surgery and a longer check for any wound issues up to one month.

Potential risks and benefits

Taking part in this study could potentially help improve pain control after foot surgery, making your recovery more comfortable. You would also be contributing valuable information that could benefit many future patients. As with any medication, there's always a chance of side effects from dexamethasone, such as higher blood sugar levels or, very rarely, issues with wound healing; the research team will be carefully monitoring you for these. You are free to change your mind and leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is 'rebound pain'?

Rebound pain is when pain suddenly becomes much stronger once the numbing injection from your surgery wears off.

What is dexamethasone?

Dexamethasone is a medicine used to reduce swelling and pain. In this study, we're testing different amounts of it.

Will I know which dose of dexamethasone I'm getting?

No, neither you nor your doctors will know which dose you're receiving. This is to ensure the study results are fair and unbiased.

How will my pain be measured?

You'll be asked to rate your pain on a simple scale from 0 (no pain) to 10 (worst pain imaginable) during phone calls after your surgery.

How long will I be involved in the study?

You'll have phone check-ups for 3 days after surgery, and your wound healing will be monitored for up to a month.

How to find out more

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

Discussion

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