Evaluation of Adrenalized Lidocaine with or without Sodium Bicarbonate on Postoperative Recovery in Ambulatory Hand and Foot Surgery

The primary objective of this study is to evaluate the effect of two **WALANT**-type local anaesthetic protocols, with or without the addition of bicarbonate, on early postoperative recovery in ambulatory hand and foot surgery. This is clinically relevant as it aims to optimize anaesthetic protocols to enhance recovery outcomes, potentially reducing postoperative complications and improving patient comfort.

Secondary objectives include:

• Sensory block installation time (min).
• Intraoperative anaesthetic block failure rate.
• Pain on injection of the WALANT anaesthetic solution.
• Intraoperative pain.
• Patient satisfaction with perioperative management.
• Postoperative pain scores (0-48h).
• Use of postoperative analgesics, particularly opioids.
• Duration of analgesic block.
• Postoperative adverse events.

The clinical trial involves a study population comprising **adult** patients aged 18 years and older, including both **male** and **female** participants. The trial focuses on individuals undergoing outpatient hand and foot surgeries, specifically procedures such as carpal tunnel release, stub finger correction, Dupuytren's disease treatment, and surgeries for hallux valgus or rigidus. Participants are required to have given free and informed consent and must be affiliated with or benefiting from health insurance. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria emphasize the eligibility for outpatient surgery under the WALANT protocol, which is a significant consideration for inclusion in the study.

The clinical trial is designed to evaluate the effect of two WALANT-type local anesthetic protocols, with or without the addition of **bicarbonate**, on early postoperative recovery in ambulatory hand and foot surgery. This study is a single-center, prospective, randomized, double-blind, non-inferiority trial. The trial is expected to commence recruitment on July 1, 2025, and conclude by August 31, 2026. Participants will be randomly assigned to receive either the test solution containing **epinephrine bitartrate** and **lidocaine hydrochloride** with bicarbonate or a comparator solution without bicarbonate. The trial will involve a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as age (≥18 years), consent, and suitability for outpatient surgery under WALANT for specific hand and foot conditions.

Following the inclusion visit, participants will undergo the surgical procedure and receive the assigned anesthetic protocol. The primary endpoint is the Quality of Recovery score (QOR 15) assessed on day 1 post-surgery. Secondary endpoints include the duration of sensory block, pain scores using the Visual Numeric Scale (VNS), satisfaction at discharge, and the quantity of analgesics taken postoperatively. Follow-up visits will be scheduled to monitor these outcomes, with assessments conducted on the day of surgery (D0), and on days 1 and 2 post-surgery (D1, D2). The end-of-study visit will occur after the final follow-up assessment, marking the completion of the participant's involvement in the trial.

Participant involvement is expected to last for a maximum of 48 hours post-surgery, with the possibility of early termination if adverse events occur, such as haematoma, scar deunion, or surgical site infection. The trial is categorized as low-intervention, with all medications used in accordance with current practice and market authorization conditions. The study aims to provide insights into the efficacy and safety of the anesthetic protocols, contributing to improved postoperative recovery strategies in ambulatory hand and foot surgeries.

The clinical trial involves the administration of several treatments, including both experimental and comparator medications. The **experimental medication** is "BICARBONATE DE SODIUM 8,4% B. BRAUN, solution pour perfusion," which contains the active substance **sodium hydrogen carbonate**. This medication is provided in the form of a solution for infusion. The maximum daily dose is 2 ml, with a total maximum dose of 2 ml over a treatment period of one day. The administration route is via infusion, and the product is manufactured by B.BRAUN MEDICAL SAS. Participant compliance will be monitored to ensure adherence to the dosing schedule.

The comparator treatment is "CHLORURE DE SODIUM FRESENIUS 0,9 %, solution pour perfusion," containing the active substance **sodium chloride**. This solution for infusion is also administered at a maximum daily dose of 2 ml, with a total maximum dose of 2 ml over one day. The administration route is infusion, and the product is manufactured by FRESENIUS KABI FRANCE S.A.S. Compliance monitoring will be conducted to ensure proper administration.

Additionally, the study includes "XYLOCAINE 10 mg/ml ADRENALINE 0,005 mg/ml, solution injectable," which contains the active substances **epinephrine bitartrate** and **lidocaine hydrochloride**. This solution for injection is administered at a maximum daily dose of 20 ml, with a total maximum dose of 20 ml over a one-day treatment period. The administration route is injection, and the product is manufactured by ASPEN PHARMA TRADING LIMITED. Participant compliance will be monitored to ensure adherence to the dosing schedule.

All medications used in this trial are chemically derived and have been authorized for use in France. The trial aims to evaluate the effect of these treatments on early postoperative recovery in ambulatory hand and foot surgery under WALANT (Wide Awake Local Anesthesia No Tourniquet) conditions. The study is designed as a single-centre, prospective, randomized, double-blind, non-inferiority trial.

Efficacy in this clinical trial will be assessed using both primary and secondary endpoints. The primary endpoint is the Quality of Recovery score (QOR 15) measured on day 1 post-surgery. This score is a validated tool used to evaluate the patient's recovery quality following surgery. Secondary endpoints include several parameters: the time to complete sensory block from injection, the necessity for re-injection of intraoperative local anesthetic, and pain scores measured using the Visual Numeric Scale (VNS) ranging from 0 to 10. These pain scores will be assessed at various stages, including the initial injection of the anesthetic solution, during surgery, and at discharge from the hospital. Additionally, VNS pain scores will be recorded at day 0, day 1, and day 2 post-surgery.

Further secondary endpoints involve the quantity of analgesics taken postoperatively within the first 48 hours, focusing on both weak and strong opioids, and the duration of sensory-motor block release. Postoperative adverse events, such as hematoma, scar deunion, re-hospitalization, and surgical site infection, will also be monitored. These efficacy parameters will be collected and analyzed at specified time points to determine the impact of the two WALANT-type local anesthetic protocols, with or without the addition of **bicarbonate**, on early postoperative recovery in ambulatory hand and foot surgery.