Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
150
Countries
1
Sites
1
Hand Surgery
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 under WALANT.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nimes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 19 Feb 2026 → ongoing
- Decision date (initial)
- 2025-09-02
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CHU de Nîmes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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 under WALANT.
Secondary objectives 9
- 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
Conditions and MedDRA coding
Hand Surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10016977 | Foot surgery | 10042613 |
| 25.0 | LLT | 10087375 | Hand reconstructive surgery | 100000004848 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Wide Awake Local Anesthesia No Tourniquet with or without bicarbonate We hypothesise that during WALANT-type local anaesthesia used in outpatient hand or foot surgery, the adrenalised lidocaine solution alone (experimental procedure) is not inferior to the adrenalised lidocaine solution with added bicarbonate (usual reference procedure) in terms of the quality of anaesthesia and analgesia (non-inferiority study).
|
Randomised Controlled | Double | [{"id":136817,"code":4,"name":"Analyst"},{"id":136815,"code":3,"name":"Monitor"},{"id":136816,"code":5,"name":"Carer"},{"id":136818,"code":2,"name":"Investigator"},{"id":136819,"code":1,"name":"Subject"}] | Walant with Bicarbonate (Control group): The reference anaesthetic protocol (control group) consisted of an ultrasound-guided injection of 20 ml (20 ml maximum dose) of lidocaine 1% adrenaline (0.005 mg/ml) buffered with 2 ml bicarbonate 8.4%. Walant without bicarbonate (experimental group): The anaesthetic protocol tested (experimental group) consisted of an ultrasound-guided injection of 20 ml (20 ml maximum dose) of lidocaine 1% adrenaline (0.005 mg/ml) with the addition of 2 ml of physiological saline. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient eligible for outpatient surgery under WALANT for : Hand surgery such as carpal tunnel, stub finger, Dupuytren's disease; Foot surgery (hallux valgus or rigidus).
- Patient has given free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated to or benefiting from a health insurance.
- Adult patient (≥18 years).
Exclusion criteria 19
- Ischaemic vascular disorders such as severe Raynaud's disease, Buerger's disease and diabetic microangiopathy.
- Scleroderma.
- Known allergy to lidocaine and possibility of cross-allergy with other amide-linked local anaesthetics.
- Severe hepatic impairment
- Acute porphyria
- Intravascular anaesthesia
- Local infiltration anaesthesia in the extremities
- Coronary insufficiency
- Ventricular rhythm disorders
- Severe arterial hypertension.
- Obstructive cardiomyopathy.
- Hyperthyroidism
- Hypovolaemia
- Patient participating in an interventional RIPH defined in category 1
- Patient in an exclusion period determined by another study
- Patient under court protection, guardianship or curatorship
- Patient unable to give consent
- Patients for whom it is impossible to provide informed information
- Pregnant, parturient or breast-feeding patients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Quality Of recovery score (QOR 15) at day 1
Secondary endpoints 9
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
XYLOCAINE 10 mg/ml ADRENALINE 0,005 mg/ml, solution injectable
PRD4875535 · Product
- Active substance
- Epinephrine Bitartrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 34009 551 659 9 6
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
XYLOCAINE 10 mg/ml ADRENALINE 0,005 mg/ml, solution injectable
PRD4875534 · Product
- Active substance
- Epinephrine Bitartrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 34009 311 521 2 5
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BICARBONATE DE SODIUM 8,4% B. BRAUN, solution pour perfusion
PRD9263053 · Product
- Active substance
- Sodium Hydrogen Carbonate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA02 — SODIUM BICARBONATE
- Marketing authorisation
- 34009 355 704 5 1
- MA holder
- B.BRAUN MEDICAL SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
CHLORURE DE SODIUM FRESENIUS 0,9 %, solution pour perfusion
PRD2503490 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 415 739 4 1
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nimes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nimes
- Address
- Place Du Professeur Robert Debre
- City
- Nimes
- Postcode
- 30900
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- CHRISTOPHE MASSEGUIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nimes
- Contact name
- CHRISTOPHE MASSEGUIN
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nimes
Anesthésie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-02-19 | 2026-02-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_FR_2024-519650-36-00 | 1.2 |
| Protocol (for publication) | D1_Protocol_FR_2024-519650-36-00_Suivi modifs | 1.2 |
| Recruitment arrangements (for publication) | D1_Document_additionnel_2024-519650-36-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_2024-519650-36-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_2024-519650-36-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_2024-519650-36-00_suivi modifs | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_RCP_BICARBONATE DE SODIUM | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_RCP_XYLOCAINE-ADRENALINE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_RCP_XYLOCAINE-ADRENALINE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-519650-36-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-22 | France | Acceptable 2025-08-20
|
2025-09-02 |