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Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT

NCT07342010 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-15

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Ambulatory surgery under Lidocaine with epinephrine alone

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.

COMBINATION_PRODUCT

Ambulatory surgery under lidocaine with epinephrine plus bicarbonate

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342010 on ClinicalTrials.gov