Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT (ROPIWA-2)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Not yet enrolling; Phase 4

Conditions: Foot Surgery; Hand Surgery; Anesthesia, Local; Walant Surgery

Treatments: Combination Product: Ambulatory surgery under Lidocaine with epinephrine alone; Combination Product: Ambulatory surgery under lidocaine with epinephrine plus bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT07342010

2024-519650-36-00

Details and patient eligibility

About

Distal upper limb and distal lower limb surgery performed under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become standard practice in ambulatory orthopedic surgery. Current infiltration mixtures used by orthopedic surgeons include lidocaine-epinephrine with the addition of 8.4% bicarbonate to reduce injection-related pain and improve analgesia duration. However, the clinical benefit of bicarbonate addition remains insufficiently supported by evidence and may increase preparation complexity and risk, including potential solution crystallization.

The aim of the ROPIWA-2 trial is to investigate whether omission of bicarbonate from the local infiltration mixture is noninferior to bicarbonate addition with respect to early postoperative quality of recovery on postoperative day 1. We hypothesize that removing bicarbonate does not impair postoperative quality of recovery after ambulatory hand and foot surgery under WALANT. Expected benefits include confirmation of a simpler, ready-to-use anesthetic solution that is easier and safer to use, without reducing patient comfort or recovery. The expected risks are those normally associated with this type of procedure.

Full description

Study context WALANT (Wide Awake Local Anesthesia No Tourniquet) is increasingly used for ambulatory hand and foot surgery, as it allows surgery without preoperative fasting and provides effective local anesthesia without a tourniquet, while promoting early functional recovery.

Sodium bicarbonate is commonly added to lidocaine-epinephrine solutions to reduce injection-related pain and prolong the duration of the anesthetic block. However, its clinical benefit remains uncertain and may increase preparation complexity.

Therefore, a robust methodological assessment of the impact of bicarbonate omission on early postoperative recovery is warranted in ambulatory WALANT surgery.

Primary objective To evaluate the effect of two WALANT local anesthesia protocols (lidocaine-epinephrine with or without bicarbonate addition) on early postoperative recovery at 24 hours after ambulatory hand and foot surgery.

Key secondary objectives A) Sensory block onset time. B) Intraoperative anesthetic block failure rate. C) Pain related to injection of the WALANT anesthetic solution. D) Intraoperative pain intensity. E) Patient satisfaction with perioperative care. F) Postoperative pain scores. G) Postoperative analgesic consumption, including opioids. H) Duration of the anesthetic block I) Postoperative adverse events.

Study design and conduct This prospective, single-center, randomized, double-blind, noninferiority trial will compare two 20 mL WALANT (Wide Awake Local Anesthesia No Tourniquet) solutions in patients scheduled for distal hand or foot ambulatory surgery.

The intervention group will receive lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL (18 mL of solution mixed with 2 mL of saline as placebo), whereas the control group will receive a similar solution including 8.4% bicarbonate (18 mL of solution mixed with 2 mL of bicarbonate). Both solutions will be administered by orthopedic surgeons prior to surgical incision.

Additional solution will be administered if sensory block is insufficient prior to incision.The maximum total lidocaine dose per patient will not exceed 800 mg in adults, in accordance with the approved labeling and standard clinical use of the drug.

Adults (≥18 years) eligible for ambulatory WALANT procedures (hand or selected foot surgeries) will be screened during the preoperative orthopedic consultation (pre-inclusion visit). All eligible patients will receive oral and written information, with at least one day between the pre-inclusion and inclusion visits to allow time for reflection and informed consent.

After written consent is obtained, patients will be randomized in a 1:1 ratio to the control group (with bicarbonate) or the intervention group (without bicarbonate). The surgical procedure under WALANT will be performed by orthopedic surgeon investigators.

Preoperative pain intensity (NRS), surgery-related anxiety (NRS), and the QuickDASH score will be recorded prior to the surgical procedure. Before hospital discharge, postoperative pain and patient satisfaction will be assessed. All patients will receive a standardized postoperative analgesic regimen.

Postoperative follow-up calls conducted by the clinical research associate will occur at 24 hours (NRS pain score, QoR-15 score, duration of the analgesic block, analgesic consumption, and adverse events) and at 48 hours (NRS pain score and adverse events). Study participation will end after the 48-hour follow-up call.

The estimated sample size is 150 patients, with 75 patients in each study arm. For the primary outcome, the noninferiority margin for the QoR-15 score is set at 6 points.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years) eligible for ambulatory surgery under WALANT for Hand surgery (including carpal tunnel release, trigger finger release, or Dupuytren's disease surgery) and foot surgery (including hallux valgus or hallux rigidus.)
• Provision of free and informed consent.
• Signed informed consent form.
• Affiliation with or beneficiary of a health insurance system

Exclusion criteria

• Ischemic vascular disorders, including severe Raynaud's disease, Buerger's disease, or diabetic microangiopathy.
• Scleroderma.
• Known allergy to lidocaine or potential cross-reactivity with other amide-type local anesthetics.
• Severe hepatic impairment.
• Acute porphyria.
• Intravascular administration of local anesthesia.
• Local anesthetic infiltration at the level of the extremities.
• Coronary artery disease.
• Ventricular arrhythmias.
• Severe arterial hypertension.
• Obstructive cardiomyopathy.
• Hyperthyroidism.
• Hypovolemia.
• Participation in an interventional clinical research study classified as category 1 (RIPH category 1).
• Ongoing exclusion period related to participation in another clinical study.
• Legal protection status (guardianship, trusteeship, or judicial protection).
• Inability to provide informed consent.
• Inability to receive or understand adequate study information.
• Pregnancy, labor, or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test prior to inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Patients undergoing hand and foot surgery with lidocaine and Epinephrine alone

Experimental group

Description:

Patients undergoing hand and foot surgery under WALANT using lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL, without bicarbonate.

Treatment:

Combination Product: Ambulatory surgery under Lidocaine with epinephrine alone

Patients undergoing hand and foot surgery with buffered lidocaine

Active Comparator group

Description:

Patients undergoing hand and foot surgery under WALANT using lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL, with bicarbonate.

Treatment:

Combination Product: Ambulatory surgery under lidocaine with epinephrine plus bicarbonate