Study of lidocaine with epinephrine and sodium bicarbonate compared to lidocaine with epinephrine alone for local anesthesia in hand and foot surgery patients

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What is this study about?

This study focuses on improving recovery after hand surgery and foot surgery performed using a technique called WALANT (Wide Awake Local Anesthesia No Tourniquet). The research examines two different local anesthetic solutions: one containing lidocaine with epinephrine, and another that adds sodium bicarbonate to this mixture. These procedures include operations for conditions such as carpal tunnel syndrome, Dupuytren’s disease, and hallux valgus (bunion).

The purpose of this research is to determine if adding sodium bicarbonate to the anesthetic solution affects how well patients recover shortly after their surgery. During the study, patients will receive one of these anesthetic solutions before their operation. The surgery will be performed while the patient is awake, using local anesthesia without the need for general anesthesia or sedation.

The study will track various aspects of recovery, including comfort levels after surgery, how quickly the anesthetic takes effect, and how long the numbness lasts. Patients will be asked about their pain levels and overall satisfaction with the procedure. The research team will also monitor for any complications that might occur after surgery.

1 Initial procedure preparation

You will receive outpatient surgery under WALANT (Wide Awake Local Anesthesia No Tourniquet) technique for either hand surgery (carpal tunnel, stub finger, Dupuytren’s disease) or foot surgery (hallux valgus or rigidus)

The medical team will prepare two possible types of local anesthetic solutions: one with bicarbonate and one without

2 Local anesthetic administration

You will receive an injection of local anesthetic solution containing lidocaine (for pain control) and epinephrine (to reduce bleeding)

The medical team will monitor the time it takes for the area to become fully numb

You will be asked to rate your pain during the injection using a scale from 0 to 10

3 Surgery procedure

The surgical procedure will be performed while you are awake

During surgery, you will be asked to rate any pain you experience on a scale from 0 to 10

Additional local anesthetic may be administered if needed

4 Same-day follow-up

Before leaving the hospital, you will be asked to rate your satisfaction on a scale from 0 to 10

You will need to record your pain level using a 0-10 scale

You will receive instructions for pain medication use

5 48-hour follow-up period

You will need to track your pain levels daily for the next two days using a 0-10 scale

Record any pain medication taken during this period

Note how long it takes for normal feeling and movement to return to the surgical area

6 Quality of recovery assessment

On the day after surgery, you will complete a Quality of Recovery questionnaire

The medical team will monitor for any complications such as bleeding, wound healing issues, or infection

Who Can Join the Study?

You must be at least 18 years old
You must be scheduled for one of these outpatient procedures under WALANT (Wide Awake Local Anesthesia No Tourniquet):
- Hand surgeries like:
  - Carpal tunnel (nerve release in the wrist)
  - Stub finger repair
  - Dupuytren’s disease (condition causing finger contracture)
- Foot surgeries like:
  - Hallux valgus (bunion – a bump on the big toe joint)
  - Hallux rigidus (stiff big toe joint)
You must have active health insurance coverage
You must be able to provide informed consent
You must sign the consent form
Both men and women can participate

Who Cannot Join the Study?

Age below 18 years or above 65 years
Known allergies to local anesthetics (medications used to numb specific areas)
Previous adverse reactions to lidocaine or epinephrine (medications used in the procedure)
Uncontrolled high blood pressure
Severe heart conditions
Current use of blood-thinning medications (anticoagulants)
Active infection in the area to be operated on
Pregnancy or breastfeeding
History of excessive bleeding during previous surgeries
Poorly controlled diabetes (high blood sugar condition)
Mental conditions that may affect ability to follow study instructions
Unable to provide informed consent
Current participation in other clinical trials
Severe anxiety or inability to tolerate local anesthesia procedures while awake

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nimes	Nimes	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2025

Trial locations

Investigated drugs:

Lidocaine with epinephrine is a local anesthetic medication combined with epinephrine (adrenaline). This combination is used to provide pain relief during surgery while minimizing bleeding. It allows surgeons to perform hand and foot procedures while patients are awake, following the WALANT technique (Wide Awake Local Anesthesia No Tourniquet).

Lidocaine with epinephrine and sodium bicarbonate is the same local anesthetic combination with the addition of sodium bicarbonate (also known as bicarbonate). The bicarbonate is added to potentially make the injection less painful and possibly improve the effectiveness of the anesthetic. This mixture is also used in WALANT procedures for hand and foot surgery.

Based on the provided data, I’ll describe the relevant medical conditions:

Hand Surgery Conditions – A group of conditions requiring surgical intervention in the hand area. These conditions can affect the bones, joints, tendons, nerves, blood vessels, and soft tissues of the hand. They may develop from injuries, repetitive motions, degenerative processes, or congenital issues. The conditions can impact hand movement, grip strength, and daily activities.

Foot Surgery Conditions – A collection of conditions that require surgical treatment in the foot region. These conditions can affect various foot structures including bones, joints, tendons, and ligaments. They may result from injuries, structural abnormalities, degenerative changes, or chronic stress on foot tissues. The conditions can affect walking ability, balance, and overall mobility.

Trial ID:

2024-519650-36-00

Protocol code:

LOCAL/2024/YG-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of lidocaine with epinephrine and sodium bicarbonate compared to lidocaine with epinephrine alone for local anesthesia in hand and foot surgery patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?