Evaluation of the effect of adrenalized lidocaine with or without bicarbonate on early postoperative recovery in ambulatory hand and foot surgery with WALANT: A Single-centre prospective randomised double-blind non-inferiority study.

2024-519650-36-00 · tracked via the Priya Life Science EU tracker

Sponsor

Centre Hospitalier Universitaire De Nimes

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Anesthesia and Analgesia

Decision date

02/09/2025

Enrollment target

150

Sites

France

Condition studied

Hand Surgery, Foot surgery

Investigational medicinal product(s)

BICARBONATE DE SODIUM 84% B. BRAUNsolution pour perfusionCHLORURE DE SODIUM FRESENIUS 09 %solution pour perfusionXYLOCAINE 10 mg/ml ADRENALINE 0005 mg/mlsolution injectableXYLOCAINE 10 mg/ml ADRENALINE 0005 mg/mlsolution injectable

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Quality Of recovery score (QOR 15) at day 1

Endpoint detail

Complete sensory block from injection (in min), Re-injection of intraoperative local anaesthetic: yes/no., Pain score on initial injection of anaesthetic solution: Visual Numeric Scale (VNS) 0-10., Intraoperative pain score during surgery: Visual Numeric Scale (VNS) 0-10., Visual Numeric Scale (VNS) satisfaction at discharge from hospital from 0 to 10., VNS (0-10) pain score at D0, D1, D2, Quantity of analgesic taken postoperatively during the first 48 hours postoperatively, in particular weak and strong opioids, Duration of sensory-motor block release (in h)., Postoperative adverse events including haematoma, scar deunion, re-hospitalisation, surgical site infection

Official registry record

This page summarises publicly available CTIS 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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