Anesthesia, LocalHand SurgeryFoot SurgeryWalant Surgery
Investigational drug(s) / intervention(s)
Ambulatory surgery under Lidocaine with epinephrine aloneAmbulatory surgery under lidocaine with epinephrine plus bicarbonate
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.
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
QoR-15 score, assessed at 24 hours postoperatively in both study arms — 24 hours after surgery 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.
Trial sites (1)
Facility
City
Region
Status
Yann GRICOURT
Nîmes
Gard
More Centre Hospitalier Universitaire de Nīmes trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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