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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ambulatory surgery under Lidocaine with epinephrine alone
Combination productThe 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
Combination productThe 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Patients undergoing hand and foot surgery with lidocaine and Epinephrine aloneExperimental treatment 1 intervention
Group B: Patients undergoing hand and foot surgery with buffered lidocaineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
QoR-15 score, assessed at 24 hours postoperatively in both study arms
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.
Time frame
24 hours after surgerySecondary outcomes
1
Sensory block onset time
Anesthetic block onset time: time (in minutes) from the initial injection to complete sensory block of the surgical area, defined as absence of sensation to pinprick testing performed at 5-minute intervals by the surgeon.
Time frame
Day 02
Intraoperative anesthetic block failure rate
Defined as the need for rescue intraoperative reinjection of local anesthetic solution by the surgeon due to persistent sensation during anesthetic block testing using nociceptive stimuli (yes/no).
Time frame
Day03
Pain related to injection of the WALANT anesthetic solution.
Patient self-assessment of pain experienced during WALANT administration, measured using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain).
Time frame
Day 04
Intraoperative pain intensity
Patient self-assessment of pain experienced during the surgical procedure, measured using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain).
Time frame
Day 0Other outcomes
1
Sex of patients
Male/Female
Time frame
Day 02
Age of patients
In years
Time frame
Day 03
Weight of patients
In kilograms
Time frame
Day 04
Height of patients
In centimeters
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov
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