Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effects of 10 vs. 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes after Total Knee Arthroplasty - a randomized, controlled, blinded study

This study is investigating how different amounts of local anaesthetic (a numbing medicine) given for a nerve block behind the knee affect pain and recovery after total knee replacement surgery. It's a randomised, controlled study, meaning participants are put into groups by chance and some will receive one amount of numbing medicine, while others get a different amount. Researchers will measure how much pain relief medicine (opioids) people need in the first 24 hours after surgery. They will also look at pain levels, how well people can walk, and their overall recovery. The aim is to find the best way to manage pain so patients can recover more comfortably and quickly.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Region Midtjylland

Enrolment target

120

Start

17 Mar 2025

Postoperative pain after Total Knee Arthroplasty

What is this study about?

Imagine you're having a knee replacement operation. Afterwards, controlling pain is really important so you can start moving and recover well. One way doctors help with pain is by giving a 'nerve block' – this is an injection of numbing medicine around the nerves behind your knee. This study is trying to find the best amount of this numbing medicine to use.

Researchers want to see if using a slightly smaller amount of the numbing medicine (called bupivacaine) works just as well as, or even better than, a larger amount. They're hoping that a smaller amount might still control pain effectively but cause fewer side effects that could slow down your recovery, like muscle weakness in your leg.

Understanding which dose is most effective for pain relief, while also helping people get up and moving sooner, is really important. The results of this study could help doctors all over the UK decide on the best way to manage pain for people having knee replacement surgery in the future, making their recovery easier and more comfortable.

Key takeaways

The study compares two doses of numbing medicine for knee replacement pain.
It aims to find the best pain relief with fewer side effects.
Researchers will track how much pain medicine you use afterwards.
Your pain, ability to walk, and recovery will be monitored.
Results could improve pain management for future knee surgery patients.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. It doesn't matter if you're male or female.

The most important thing is that you're going to have a total knee replacement operation. This study is specifically for people undergoing that type of surgery.

There might be other health conditions or medications that would mean you couldn't join, but the researchers would discuss all of these details with you or your doctor to make sure it's safe for you to take part.

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 to have a total knee replacement operation?
Is your medical team telling you about this study?
Do you understand what being in the study involves?

Answer every question to see your result.

What does participation involve?

If you join this study, you'd be taking part for a short period around your knee replacement surgery. Before your operation, you might have some pain assessments. During your surgery, you would receive one of two pre-determined amounts of local anaesthetic for a nerve block. After your surgery, the research team would keep track of how much pain medicine you need in the first 24 hours. You would also be asked to rate your pain at certain times (at 6 and 24 hours after surgery) and try to walk a short distance with crutches. They will also check your leg strength and ask you about your recovery at 24 hours after surgery. There are no extra visits beyond your usual hospital stay for this study, and the assessments are integrated into your recovery process.

Potential risks and benefits

Participating in this study might offer the benefit of potentially finding a better way to manage pain after your knee surgery, which could lead to a smoother recovery for you, and help future patients. As with any medical procedure, there are always some risks involved, even with nerve blocks, though these are rare and doctors take every precaution. You will receive a standard pain block, but the amount of medicine used might be different from what you would normally get. You are free to withdraw from the study at any time without it affecting your medical care. The medical team will explain all potential risks and benefits in detail before you decide to take part.

Locations (1)

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

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Unverified
Denmark

Common questions

What exactly is a 'nerve block'?

It's an injection of numbing medicine near nerves to stop pain signals from getting to your brain. This helps with pain relief in a specific area, like your knee after surgery.

Will I know which dose of numbing medicine I'm getting?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you received the smaller or larger dose. This helps make the study results fair and unbiased.

What kind of pain medicine do they mean by 'opioid consumption'?

Opioids are strong painkiller medications often given after surgery. The study measures how much of these you might need to control your pain in the first 24 hours.

How will my pain be measured?

You'll be asked to rate your pain on a simple scale, usually from 0 (no pain) to 10 (worst pain imaginable), at different times after your surgery.

What if my pain isn't well controlled during the study?

Your medical team will always make sure your pain is managed effectively, regardless of your participation in the study. Your comfort is their priority.