Not yet recruitingPHASE4INTERVENTIONAL

Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT

Imagine you're having a minor hand or foot operation while you're awake, using a special local anaesthetic called WALANT. Sometimes, a chemical called bicarbonate is added to this anaesthetic to reduce pain when it's injected and make the numbing last longer. However, we're not entirely sure if adding bicarbonate really makes a big difference, and it can make preparing the anaesthetic more complicated. This study aims to find out if taking out the bicarbonate from the local anaesthetic mix has any impact on how well you recover after surgery. We think that removing it won't make your recovery any worse. The main goal is to find a simpler, ready-to-use anaesthetic that's easier and potentially safer to use, while still keeping you comfortable and helping you recover well.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

150

Start

01 Feb 2026

Estimated completion

01 Feb 2027

Anesthesia, Local Hand Surgery Foot Surgery Walant Surgery

What is this study about?

When you have certain operations on your hand or foot, especially smaller ones, doctors often use a method called WALANT (Wide Awake Local Anesthesia No Tourniquet). This means you're awake during the surgery, and the area being operated on is numbed with an injection. It's becoming a popular choice because you don't need to fast beforehand, and it helps you get back to using your hand or foot sooner.

Currently, the numbing medicine often contains a mix of lidocaine (which numbs the area) and epinephrine (which helps the numbing last longer and reduces bleeding). Sometimes, another chemical called bicarbonate is added to this mix. The idea is that bicarbonate might make the injection sting less and help the anaesthetic work better for longer. However, we don't have strong proof that adding bicarbonate makes a big difference, and it can actually make the anaesthetic a bit trickier to prepare – sometimes it can even cause small crystals to form, which isn't ideal.

This study wants to explore whether forgetting the bicarbonate from the anaesthetic mix affects how well you recover after your hand or foot surgery. We are comparing two groups: one receiving the anaesthetic with bicarbonate, and another receiving it without. We believe that leaving out the bicarbonate won't make your recovery any worse and could lead to a simpler, safer anaesthetic that's easier for doctors to use, without reducing your comfort or how quickly you get better.

Key takeaways

This study evaluates a common local anaesthetic for hand and foot surgery.
It aims to see if an ingredient called bicarbonate is truly needed for good recovery.
The goal is a simpler, potentially safer anaesthetic solution that doesn't reduce patient comfort.
Participants will receive either the anaesthetic with or without bicarbonate, unknown to them or their doctors.
This research could improve future anaesthetic practices for specific surgeries.

Who may be eligible?

This study is looking for adults aged 18 and over who are scheduled for certain types of hand or foot surgery using the WALANT anaesthetic method. This includes common procedures like carpal tunnel release, trigger finger release, bunion surgery (hallux valgus), or surgery for stiff big toe (hallux rigidus).

You won't be able to join if you have certain medical conditions, such as severe heart problems, serious blood vessel issues (like Raynaud's disease or Buerger's disease), or if you're allergic to lidocaine or similar numbing medicines. We also can't include you if you have severe liver problems, certain rare blood disorders, or if you're pregnant, breastfeeding, or trying to get pregnant.

It's also important that you're able to understand what the study involves and can give your full permission to take part. If you're already involved in another clinical study or have certain legal protections, you might not be eligible.

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 an adult aged 18 or over?
Are you having a specific hand or foot surgery (like carpal tunnel or bunion surgery) using local anaesthetic?
Do you NOT have severe heart conditions, serious blood vessel problems, or a known allergy to lidocaine?
Are you NOT pregnant or breastfeeding?
Can you understand the study information and give your consent freely?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive the standard local anaesthetic mix with bicarbonate, and the other group will receive the same anaesthetic but with a salt solution added instead of bicarbonate. You and your surgical team won't know which mixture you've received.

The anaesthetic will be given by your orthopaedic surgeon just before your hand or foot surgery, as they normally would. We'll be closely monitoring you during and after your surgery. We'll ask you about any pain you feel when the injection is given, and how much pain you have during and after the operation. We'll also check how quickly the anaesthetic starts to work and how long it lasts.

On the day after your surgery, we'll ask you questions about your recovery and how satisfied you are with your care. We'll also record any pain relief you use and any side effects you might experience. The total duration of your active participation, beyond your usual surgery and recovery, will be focused on these assessments around your operation day.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to our understanding of the best and simplest way to deliver local anaesthesia for certain hand and foot surgeries, potentially leading to improved patient care in the future. We believe that by removing bicarbonate, we could create a simpler and safer anaesthetic solution without compromising your comfort or recovery. The risks involved are generally those that you would face with any local anaesthetic procedure for this type of surgery, such as local pain or bruising from the injection. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Yann GRICOURT
Verified postcode
Nîmes, France

Common questions

What is WALANT surgery?

WALANT stands for Wide Awake Local Anesthesia No Tourniquet. It means you're awake during your operation, and only the area being operated on is numbed with a special injection, without needing a tight band (tourniquet) on your arm or leg.

What is bicarbonate in this context?

Bicarbonate is a chemical that is sometimes added to local anaesthetics. It's thought to reduce discomfort during the injection and help the numbing medicine work effectively for longer. This study is trying to find out if it's really necessary.

Will I know if I'm getting bicarbonate or not?

No, this is a 'double-blind' study. Neither you nor your doctors will know which anaesthetic mix you're receiving. This helps make sure the results are as fair and unbiased as possible.

What kind of surgeries are included?

The study includes common hand surgeries like carpal tunnel release and trigger finger release, as well as foot surgeries like bunion correction or stiff big toe surgery.

What are the main things the study wants to find out?

The study mainly wants to see if removing bicarbonate from the anaesthetic mix still allows for a good recovery after surgery, without increasing pain or discomfort, and whether it makes the process simpler and safer.

How to find out more

Yann GRICOURT, Dr.

gricourt.yann@gmail.com +334.66.68.30.50 Official trial record

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