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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519650-36-00
Acronym
LOCAL/2024/YG-01
Enrollment
150
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Surgery, Foot surgery

Brief summary

Quality Of recovery score (QOR 15) at day 1

Detailed description

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

Interventions

DRUGBICARBONATE DE SODIUM 8
DRUG4% B. BRAUN
DRUGsolution pour perfusion
DRUGCHLORURE DE SODIUM FRESENIUS 0
DRUG9 %
DRUGXYLOCAINE 10 mg/ml ADRENALINE 0
DRUG005 mg/ml
DRUGsolution injectable

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Quality Of recovery score (QOR 15) at day 1—

Secondary

MeasureTime frame
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—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026