Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT

Starting soon · Phase 4 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT07342010

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

150

Starts

2026-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

Where it is running

• Yann GRICOURT — Nîmes, Gard, France

Full record on ClinicalTrials.gov

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