Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Intravenous lidocaine and post operative recovery after liver surgery – a randomized double blinded study

This study is investigating if a common local anaesthetic, lidocaine, given through a vein, can help patients recover better after surgery for liver tumours. Liver surgery can be painful, and doctors often use strong pain medications called opioids. This research aims to find out if lidocaine can help reduce the amount of opioids needed in the first 24 to 48 hours after surgery. By potentially lowering opioid use, the study hopes to improve recovery, reduce side effects like nausea, and possibly shorten hospital stays. Patients will be randomly given either lidocaine or a dummy solution, and researchers will compare how much pain relief they need and how well they recover.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Region Skane

Enrolment target

124

Start

30 Sep 2024

Patients with liver tumours that have liver surgery performed

What is this study about?

Imagine you or someone you know needs surgery on their liver because of a tumour. After such a big operation, managing pain is very important, and doctors often use strong pain medications called opioids. While very effective, opioids can sometimes cause side effects like nausea or make you feel sleepy.

This study is looking into whether a medicine called lidocaine, which is often used to numb parts of the body, could help with pain after liver surgery when given through a drip (into a vein). The main idea is to see if giving lidocaine during and after the operation can reduce the total amount of opioid pain relief a patient needs in the first day or two. If it works, it could mean patients feel more comfortable, experience fewer side effects from opioids, and potentially have a smoother, quicker recovery.

Researchers will carefully compare patients who receive lidocaine with those who receive a 'dummy' solution (a saline drip, which looks the same but has no active medicine) to see the differences in pain relief needed, how quickly they recover, and their overall comfort. This is a common way to test new treatments to make sure the results are fair and accurate.

Key takeaways

Investigating lidocaine for pain after liver surgery.
Aims to reduce strong pain medication (opioids).
Participation involves receiving lidocaine or a dummy solution via drip.
Open to adults (18+) having liver tumour surgery.
Could lead to better recovery and fewer side effects.
Your decision to join is completely voluntary.

Who may be eligible?

This study is looking for adults aged 18 or older. It is open to both men and women.

To be considered for this study, you must be having surgery on your liver because of tumours. The medical team will check other health details to make sure the study is safe and suitable for you, as not everyone can take part.

If you are interested, your doctors will be able to tell you if you meet all the necessary requirements to join this research.

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 having surgery for liver tumours?
Are you able to follow study instructions?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group will receive lidocaine through a drip during and shortly after your liver surgery. The other group will receive a 'dummy' solution (salt water) through a drip, which looks exactly the same, so neither you nor your doctors will know which you are receiving. This is called a 'double-blind' study and helps ensure the results are unbiased.

Your pain levels will be regularly checked using a simple scale, and the amount of pain relief you use will be carefully recorded. The study will also look at other aspects of your recovery, such as how soon your bowels start working again, if you feel sick, and how long you stay in hospital. You will have regular checks by the medical team during your hospital stay and potentially some follow-up questions after you leave, but this will all be carried out as part of your standard medical care.

Potential risks and benefits

Participating in this study might offer the benefit of potentially needing less strong pain relief after your surgery, which could lead to fewer side effects like nausea. However, there's no guarantee that lidocaine will work for everyone, or that it will be more effective than standard treatment. As with any medication, lidocaine can have side effects, though serious ones are rare when given by a drip. These will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without affecting the quality of 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
Sweden

Common questions

What is lidocaine?

Lidocaine is a medicine often used to numb parts of the body. In this study, it's given through a drip to see if it helps with overall pain after surgery.

Will I know if I'm getting lidocaine or the dummy solution?

No, neither you nor your doctors will know which treatment you are receiving. This is to make sure the study results are fair and accurate.

What kind of surgery is this study for?

This study is for patients undergoing surgery on their liver because of tumours.

What happens if I want to leave the study?

You can leave the study at any time, for any reason, and it will not affect the medical care you receive.

Will my regular pain relief be affected?

No, you will still receive all the usual pain relief your doctors think is best for you, regardless of your participation in the study.