Bicarbonate Addition to Lidocaine-Epinephrine in Surgery Under WALANT
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ambulatory surgery under Lidocaine with epinephrine alone, Ambulatory surgery under lidocaine with epinephrine plus bicarbonate.
- Who it may be relevant to
- Registry conditions: Anesthesia, Local, Hand Surgery, Foot Surgery, Walant Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Lidocaine With Adrenaline, With or Without Bicarbonate, on Early Postoperative Recovery in WALLANT-type Outpatient Hand and Foot Surgery: A Prospective, Randomised, Double-blind, Single-centre Non-inferiority Study.
Overview
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.
Detailed description
Study context WALANT (Wide Awake Local Anesthesia No Tourniquet) is increasingly used for ambulatory hand and foot surgery, as it allows surgery without preoperative fasting and provides effective local anesthesia without a tourniquet, while promoting early functional recovery.
Sodium bicarbonate is commonly added to lidocaine-epinephrine solutions to reduce injection-related pain and prolong the duration of the anesthetic block. However, its clinical benefit remains uncertain and may increase preparation complexity.
Therefore, a robust methodological assessment of the impact of bicarbonate omission on early postoperative recovery is warranted in ambulatory WALANT surgery.
Primary objective To evaluate the effect of two WALANT local anesthesia protocols (lidocaine-epinephrine with or without bicarbonate addition) on early postoperative recovery at 24 hours after ambulatory hand and foot surgery.
Key secondary objectives A) Sensory block onset time. B) Intraoperative anesthetic block failure rate. C) Pain related to injection of the WALANT anesthetic solution. D) Intraoperative pain intensity. E) Patient satisfaction with perioperative care. F) Postoperative pain scores. G) Postoperative analgesic consumption, including opioids. H) Duration of the anesthetic block I) Postoperative adverse events.
Study design and conduct This prospective, single-center, randomized, double-blind, noninferiority trial will compare two 20 mL WALANT (Wide Awake Local Anesthesia No Tourniquet) solutions in patients scheduled for distal hand or foot ambulatory surgery.
The intervention group will receive lidocaine 5 mg/mL combined with epinephrine 0.005 mg/mL (18 mL of solution mixed with 2 mL of saline as placebo), whereas the control group will receive a similar solution including 8.4% bicarbonate (18 mL of solution mixed with 2 mL of bicarbonate). Both solutions will be administered by orthopedic surgeons prior to surgical incision.
Additional solution will be administered if sensory block is insufficient prior to incision.The maximum total lidocaine dose per patient will not exceed 800 mg in adults, in accordance with the approved labeling and standard clinical use of the drug.
Adults (≥18 years) eligible for ambulatory WALANT procedures (hand or selected foot surgeries) will be screened during the preoperative orthopedic consultation (pre-inclusion visit). All eligible patients will receive oral and written information, with at least one day between the pre-inclusion and inclusion visits to allow time for reflection and informed consent.
After written consent is obtained, patients will be randomized in a 1:1 ratio to the control group (with bicarbonate) or the intervention group (without bicarbonate). The surgical procedure under WALANT will be performed by orthopedic surgeon investigators.
Preoperative pain intensity (NRS), surgery-related anxiety (NRS), and the QuickDASH score will be recorded prior to the surgical procedure. Before hospital discharge, postoperative pain and patient satisfaction will be assessed. All patients will receive a standardized postoperative analgesic regimen.
Postoperative follow-up calls conducted by the clinical research associate will occur at 24 hours (NRS pain score, QoR-15 score, duration of the analgesic block, analgesic consumption, and adverse events) and at 48 hours (NRS pain score and adverse events). Study participation will end after the 48-hour follow-up call.
The estimated sample size is 150 patients, with 75 patients in each study arm. For the primary outcome, the noninferiority margin for the QoR-15 score is set at 6 points.
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.
Primary outcome measures
- QoR-15 score, assessed at 24 hours postoperatively in both study arms [Time frame: 24 hours after surgery]
Secondary outcome measures (9)
- Sensory block onset time [Time frame: Day 0]
- Intraoperative anesthetic block failure rate [Time frame: Day0]
- Pain related to injection of the WALANT anesthetic solution. [Time frame: Day 0]
- Intraoperative pain intensity [Time frame: Day 0]
- Patient satisfaction with perioperative care [Time frame: Day 0]
- Postoperative pain scores [Time frame: Day 2]
- Postoperative analgesic consumption, including opioids [Time frame: Day 2]
- Duration of the anesthetic block [Time frame: Day 1]
- Postoperative adverse events [Time frame: Day 2]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Yann GRICOURT — Nîmes
Identifiers
NCT: NCT07342010 · 2024-519650-36-00