Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT

NCT07342010 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-519650-36-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

lidocaine,; bicarbonates,; Quality of recovery; Walant

Outcome Measures

Primary Outcomes (1)

• QoR-15 score, assessed at 24 hours postoperatively in both study arms

  QoR-15 score, assessed at 24 hours postoperatively in both study arms. This validated questionnaire includes 15 items covering five dimensions: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated on a 1-10 scale, with a total score ranging from 15 to 150.

  24 hours after surgery

Secondary Outcomes (9)

• Sensory block onset time

  Day 0

• Intraoperative anesthetic block failure rate

  Day0

• Pain related to injection of the WALANT anesthetic solution.

  Day 0

• Intraoperative pain intensity

  Day 0

• Patient satisfaction with perioperative care

  Day 0

Other Outcomes (13)

• Sex of patients

  Day 0

• Age of patients

  Day 0

• Weight of patients

  Day 0

Study Arms (2)

Patients undergoing hand and foot surgery with lidocaine and Epinephrine alone

EXPERIMENTAL

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

Combination Product: Ambulatory surgery under Lidocaine with epinephrine alone

Patients undergoing hand and foot surgery with buffered lidocaine

ACTIVE COMPARATOR

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

Combination Product: Ambulatory surgery under lidocaine with epinephrine plus bicarbonate

Interventions

Ambulatory surgery under Lidocaine with epinephrine alone COMBINATION_PRODUCT

The anesthetic solution will consist of lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL, administered as 18 mL (90 mg of lidocaine) plus 2 mL of saline (placebo), for a total volume of 20 mL Additional solution will be administered if sensory block is insufficient prior to incision.

Also known as: Local infiltration with lidocaine-epinephrine

Patients undergoing hand and foot surgery with lidocaine and Epinephrine alone

Ambulatory surgery under lidocaine with epinephrine plus bicarbonate COMBINATION_PRODUCT

The anesthetic solution will consist of lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL, administered as 18 mL (90 mg of lidocaine) plus 2 mL of 8.4% bicarbonate, for a total volume of 20 mL. Additional solution will be administered if sensory block is insufficient prior to incision.

Also known as: Local infiltration with lidocaine-epinephrine and bicarbonate

Patients undergoing hand and foot surgery with buffered lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Legal protection status (guardianship, trusteeship, or judicial protection).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Yann GRICOURT

Nîmes, Gard, 30029, France

Location

MeSH Terms

Interventions

Epinephrine; Bicarbonates

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Central Study Contacts

Yann GRICOURT, Dr.

CONTACT

+334.66.68.30.50; gricourt.yann@gmail.com

Anissa MEGZARI

CONTACT

+334.66.68.30.50; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the WALANT local infiltration solution administered. Investigators performing the local anesthesia and the surgical procedure, as well as outcome assessors (investigator-delegated evaluators, hospital clinical research associates, and evaluating physicians), will also be blinded to treatment allocation. Preoperative and postoperative assessments will be performed by providers different from those who performed the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, randomized (1:1 ratio), double-blind, noninferiority trial comparing two WALANT solutions (with or without bicarbonate addition) in patients scheduled for distal hand or foot ambulatory surgery.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)