Clinical trial • Not applicable • Other
Epinephrine bitartrate; Lidocaine hydrochloride for Hand surgery | Foot surgery
Not applicable trial of Epinephrine bitartrate; Lidocaine hydrochloride for Hand surgery | Foot surgery.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Hand surgery | Foot surgery
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 02-09-2025
Trial design
Randomised, walant with bicarbonate (control group): 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): 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. Not applicable trial across 1 site in France.
- Randomised
- Yes
- Comparator
- Walant with Bicarbonate (Control group): 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): 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.
- Target Sample Size
- 150
Eligibility
Recruits 150 Vulnerable populations are excluded: 'Patient under court protection, guardianship or curatorship'; 'Patient unable to give consent'; 'Patients for whom it is impossible to provide informed information'. Only adults (≥18) are eligible and informed consent is required ('Patient has given free and informed consent' and 'Patient who has signed the consent form')..
- Pregnancy Exclusion
- Pregnant, parturient or breast-feeding patients
- Vulnerable Population
- Vulnerable populations are excluded: 'Patient under court protection, guardianship or curatorship'; 'Patient unable to give consent'; 'Patients for whom it is impossible to provide informed information'. Only adults (≥18) are eligible and informed consent is required ('Patient has given free and informed consent' and 'Patient who has signed the consent form').
Inclusion criteria
- {"criterion_text":"- 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).\n- Patient has given free and informed consent.\n- Patient who has signed the consent form.\n- Patient affiliated to or benefiting from a health insurance.\n- Adult patient (≥18 years)."}
Exclusion criteria
- {"criterion_text":"- Ischaemic vascular disorders such as severe Raynaud's disease, Buerger's disease and diabetic microangiopathy.\n- Severe arterial hypertension.\n- Obstructive cardiomyopathy.\n- Hyperthyroidism\n- Hypovolaemia\n- Patient participating in an interventional RIPH defined in category 1\n- Patient in an exclusion period determined by another study\n- Patient under court protection, guardianship or curatorship\n- Patient unable to give consent\n- Patients for whom it is impossible to provide informed information\n- Pregnant, parturient or breast-feeding patients\n- Scleroderma.\n- Known allergy to lidocaine and possibility of cross-allergy with other amide-linked local anaesthetics.\n- Severe hepatic impairment\n- Acute porphyria\n- Intravascular anaesthesia\n- Local infiltration anaesthesia in the extremities\n- Coronary insufficiency\n- Ventricular rhythm disorders"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Quality Of recovery score (QOR 15) at day 1","definition_or_measurement_approach":"Quality of Recovery-15 (QOR-15) score measured at day 1."}
Secondary endpoints
- {"endpoint_text":"- Complete sensory block from injection (in min)","definition_or_measurement_approach":"Time (minutes) from injection to complete sensory block."}
- {"endpoint_text":"- Re-injection of intraoperative local anaesthetic: yes/no.","definition_or_measurement_approach":"Binary outcome (yes/no) indicating whether intraoperative re-injection of local anaesthetic was performed."}
- {"endpoint_text":"- Pain score on initial injection of anaesthetic solution: Visual Numeric Scale (VNS) 0-10.","definition_or_measurement_approach":"Pain assessed at initial injection using Visual Numeric Scale (VNS) 0-10."}
- {"endpoint_text":"- Intraoperative pain score during surgery: Visual Numeric Scale (VNS) 0-10.","definition_or_measurement_approach":"Intraoperative pain assessed during surgery using VNS 0-10."}
- {"endpoint_text":"- Visual Numeric Scale (VNS) satisfaction at discharge from hospital from 0 to 10.","definition_or_measurement_approach":"Patient satisfaction at discharge measured by VNS 0-10."}
- {"endpoint_text":"- VNS (0-10) pain score at D0, D1, D2","definition_or_measurement_approach":"Pain scores measured on days 0, 1 and 2 using VNS 0-10."}
- {"endpoint_text":"- Quantity of analgesic taken postoperatively during the first 48 hours postoperatively, in particular weak and strong opioids","definition_or_measurement_approach":"Amount and type of postoperative analgesics taken during the first 48 hours, with particular attention to weak and strong opioids."}
- {"endpoint_text":"- Duration of sensory-motor block release (in h).","definition_or_measurement_approach":"Duration in hours until sensory-motor block resolution."}
- {"endpoint_text":"- Postoperative adverse events including haematoma, scar deunion, re-hospitalisation, surgical site infection","definition_or_measurement_approach":"Collection of specified postoperative adverse events: haematoma, scar dehiscence, re-hospitalisation, surgical site infection."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 13
- Consent Approach
- Informed consent is required: 'Patient has given free and informed consent' and 'Patient who has signed the consent form'. Only adults (≥18) are eligible. Subject information and informed consent form document (L1_SIS and ICF adult) is provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 150
France
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 64
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Anesthésie
- Contact Person Name
- Yann GRICOURT
- Contact Person Email
- yann.gricourt@chu-nimes.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nimes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- XYLOCAINE 10 mg/ml ADRENALINE 0,005 mg/ml, solution injectable
- Active Substance
- Epinephrine bitartrate; Lidocaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION
- Route
- SOLUTION FOR INJECTION
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 34009 551 659 9 6)
- Starting Dose
- Ultrasound-guided injection of 20 ml of lidocaine 1% with adrenaline 0.005 mg/ml (maximum 20 ml)
- Maximum Dose
- 20 ml
- Investigational Product Name
- BICARBONATE DE SODIUM 8,4% B. BRAUN, solution pour perfusion
- Active Substance
- Sodium hydrogen carbonate
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 34009 355 704 5 1)
- Starting Dose
- 2 ml of bicarbonate 8.4% added to the lidocaine/adrenaline solution
- Maximum Dose
- 2 ml
- Investigational Product Name
- CHLORURE DE SODIUM FRESENIUS 0,9 %, solution pour perfusion
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- SOLUTION FOR INFUSION
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 34009 415 739 4 1; mrpNumber: FR/H/0218/001)
- Starting Dose
- 2 ml of physiological saline added to the lidocaine/adrenaline solution
- Maximum Dose
- 2 ml
- Combination Treatment
- Yes
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