Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ambulatory surgery under Lidocaine with epinephrine alone
  • Ambulatory surgery under lidocaine with epinephrine plus bicarbonate

Treatment groups

150 Participants
are divided into 2 treatment groups