Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Perioperative oral analgesia versus intravenous analgesia for knee arthroscopy, a randomized, double-blinded, non-inferiority trial. OVIKA-trial - S68618

The OVIKA study (S68618) is exploring how best to manage pain after a common knee surgery called knee arthroscopy. This type of surgery is often done to diagnose or treat knee problems. Researchers want to find out if taking pain relief tablets by mouth is just as good at controlling pain as getting pain relief through a drip into a vein (IV). They will be carefully measuring pain levels before the operation and at different times afterwards until patients go home. They'll also check if patients need extra pain medication, how quickly they recover, and how they feel after the operation. This study aims to help doctors decide the best and most comfortable way to give pain relief after this type of knee surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

108

Start

03 Jun 2024

Postoperative pain relief after knee arthroscopy

What is this study about?

This study, known as the OVIKA trial, is all about finding the best way to handle pain after a common knee operation, specifically a procedure called knee arthroscopy. This surgery is often done to look inside the knee joint, fix small problems, or clean things up. Many people have this operation, and managing pain afterwards is really important for a smooth recovery.

Currently, some patients get their pain medicine through an IV drip, which goes directly into a vein. Other patients might take tablets by mouth. This study wants to see if taking pain relief as simple tablets works just as well, or even better, than the IV drip for managing pain. They are comparing common pain medications like paracetamol and ibuprofen, which are often used for pain relief.

The main goal is to measure how much pain people feel using a simple pain scale. They'll ask about pain before the operation and then at various times afterwards, right up until you are ready to go home. They will also look at how quickly people recover, if they need any stronger pain medicines, and how they feel overall. The results of this study will help doctors choose the most effective and comfortable pain relief methods for patients undergoing knee arthroscopy in the future.

Key takeaways

Compares oral tablets vs. IV drip for pain after knee surgery.
Aims to find the most effective and comfortable pain relief.
Participation involves routine monitoring of pain and recovery.
Uses common pain medications like paracetamol and ibuprofen.
Open to adults aged 18 and over having minor knee arthroscopy.

Who may be eligible?

This study is open to adults aged 18 years and older. Both men and women can take part.

You would be considered for this study if you are planning to have a minor knee arthroscopy, which is a common keyhole surgery on the knee.

Before joining, doctors will check your overall health and make sure this study is right for you. They will explain any reasons why you might not be able to join, ensuring your safety and the accuracy of the study results.

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.

Are you 18 years old or older?
Are you scheduled for a minor knee arthroscopy (keyhole surgery)?
Are you generally in good health?
Are you able to take medication by mouth if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive pain relief either through a drip (IV) or as tablets by mouth. The study is "double-blinded," meaning neither you nor the doctors will know which treatment you are receiving. You will have your pain levels measured using a simple scale before your operation and at different times afterwards while you are in the hospital. Doctors will also track aspects like whether you need any extra pain medication, how quickly you feel ready to go home, and how you're feeling for up to 24 hours after you leave the hospital. There are no extra hospital visits required beyond your standard surgical care. The total duration of your active participation would be around 24 hours after discharge.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to medical knowledge that could improve pain management for future patients undergoing knee surgery. You will also receive careful monitoring of your pain and recovery. Potential risks are generally low, as the treatments involve commonly used pain medications. However, as with any medication, there's a chance of side effects, which will be explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is knee arthroscopy?

Knee arthroscopy is a common 'keyhole' surgery where doctors use a tiny camera to look inside your knee, diagnose problems, or make small repairs.

What is the study trying to find out?

The study wants to see if taking pain relief tablets by mouth works just as well as getting pain relief through an IV drip after a knee arthroscopy operation.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the doctors will know if you're getting the tablets or the IV for pain relief. This helps make the study fair.

Do I have to do anything extra after I leave the hospital?

You might be asked about your pain levels for up to 24 hours after you leave, but there are no extra hospital visits required beyond your normal post-operative care.

Can I stop participating in the study?

Yes, you are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.