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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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

10 criteria

  • 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 trial?

14 criteria

  • 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
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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.

What is already known about the treatment

  • Lidocaine with epinephrine

    A local anesthetic solution used in WALANT (Wide Awake Local Anesthesia No Tourniquet) technique for hand and foot surgery. This medication combines lidocaine, which blocks nerve signals to prevent pain, with epinephrine (adrenaline) that constricts blood vessels to reduce bleeding and prolong the anesthetic effect. It is administered through local injection into the surgical site, allowing patients to remain awake during the procedure while providing effective pain control and minimizing blood loss.

  • Bicarbonate-buffered lidocaine with epinephrine

    A modified version of the standard WALANT solution where sodium bicarbonate is added to the lidocaine-epinephrine mixture to reduce injection pain and improve patient comfort. The bicarbonate helps neutralize the acidic pH of the anesthetic solution, potentially leading to faster onset of action and less burning sensation during administration. This buffered solution is administered through local injection and is being studied for its effects on post-operative recovery in hand and foot surgery.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519650-36-00Protocol codeLOCAL/2024/YG-01Estimated enrolment150 patientsSponsorCentre Hospitalier Universitaire De Nimes

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