A Phase 1 interventional study of Ambulatory surgery under Lidocaine alone and Ambulatory surgery under a combination of Lidocaine and Ropivacaine in Anesthesia, Local, Hand Surgery and Wrist Surgery, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 1, Interventional, and Treatment
Distal surgery of the upper limb under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become the standard care in orthopedic surgery. The principle is that the operator infiltrates the whole surgical area with a 1% lidocaine solution combined with adrenaline (diluted to 1/200,000) so that all distal surgery of the upper limb can be performed without a tourniquet. Thus, the perioperative course and management of the patient in the operating room and the constraints inherent to general anesthesia are largely reduced. Also, the material cost is considerably reduced. However, WALANT often induces significant pain when the patient leaves the operating room to return home. This effect is related to the pharmacological formulation of lidocaine which has a short half-life (\< 3h). To reduce this inconvenience of early block removal, adding a local anesthetic with a longer duration of action (ropivacaine) to lidocaine would extend the duration of the analgesic, improving postoperative experience and satisfaction. The main objective of this research is to evaluate the effect of two WALANT anesthesia protocols (with or without the addition of ropivacaine) on the postoperative experience of patients (QoR-40 questionnaire) 48 hours after outpatient hand surgery.
Secondary objectives include the evaluation of short-term pain (Day 0 to Day 7), chronicisation of pain at 3 months, patient satisfaction regarding perioperative management and tolerance in both groups.
This is a monocentric, prospective, randomized, single-blind study. 80 adult patients, eligible for outpatient surgery under under WALANT for hand surgery such as carpal tunnel, stub finger, Dupuytren's disease or elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome, will be recruited during their care in the orthopedic and trauma surgery department at Nîmes University Hospital over an estimated period of 12 months. After receiving information, the intervention visit will be planned within 21 days. After collecting consent and checking the selection criteria, patients will be randomized (1:1 stratified according to hand/elbow surgery) for a procedure under WALANT anesthesia with 10 to 20 ml of 1% lidocaine (10 mg/mL) (depending on the procedure) combined with adrenaline (0.005mg/ml) with or without the addition of 15mg ropivacaine. An evaluation of the pain via a visual analog scale (0 to 10) will be carried out before discharge from the service and by telephone on Day 1 according to the current care then at Days 2 and 3 and 7 for the research. The patients will also have to answer questionnaires on their perioperative management (Evaluation of the experience of local anaesthesia or EVAN-LR) before leaving the department and then on the postoperative experience (Quality of Recovery or QoR-40) at D2 and the possible "chronicisation" of pain at 3 months (neuropathic pain or DN4) by telephone. Possible adverse events will be collected up to D7.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 91 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
Combination Product: Ambulatory surgery under a combination of Lidocaine and Ropivacaine
Patients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
Combination Product: Ambulatory surgery under Lidocaine alone
In this conventional procedure group, the anesthetic solution is administered subcutaneously and by infiltration into the surgical area. A maximum volume of 20 ml (dose dictated by the operation) of the solution is thus injected by the operator: Lidocaine 10mg/mL combined with adrenaline 0.005mg/mL administered at a dose of 10 to 20 mL, i.e. a total of 50 to 200 mg of lidocaine.
Also known as: Local anesthesia with lidocaine alone
In this experimental procedure group, the anesthetic solution is administered subcutaneously and by infiltration into the surgical area. A maximum volume of 20 ml (dose dictated by the operation) of the solution is thus injected by the operator: Lidocaine 10mg/mL combined with adrenaline 0.005mg/mL administered at a dose of 18 mL + ropivacaine 7.5 mg/mL 2 mL or 15 mg. For a total of 20 mL: lidocaine 9mg/mL, ropivacaine 0.75 mg/mL, adrenaline 0.005 mg/mL
Also known as: Local anesthesia with lidocaine and ropivacaine
Experimental group: experience of patients in the Lidocaine + Ropivacaine group
The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative. This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.
Time frame: 48 hours after surgery
Control group: experience of patients in the Lidocaine alone group
The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative. This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.
Time frame: 48 hours after surgery
Pain on a numerical visual analog scale : Experimental group
Pain will be evaluated on a numerical visual analog scale in the experimental group. The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.
Time frame: Day 0
Pain on a numerical visual analog scale : Experimental group
Pain will be evaluated on a numerical visual analog scale in the experimental group. The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.
Time frame: Day 1
Pain on a numerical visual analog scale : Experimental group
Pain will be evaluated on a numerical visual analog scale in the experimental group. The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.
Time frame: Day 2
Pain on a numerical visual analog scale : Experimental group
Pain will be evaluated on a numerical visual analog scale in the experimental group. The scale ranges from 0 to 10 in which 0 = no pain and 10 = worst possible pain.
Time frame: Day 7
Neuropathic pain according to the DN4 questionnaire: Experimental group
Pain in the experimental group will be evaluated by telephone using the DN4 questionnaire. This is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The DN4 (which stands for Douleur Neuropathique 4 i.e. Neuropathic Pain 4) is one of the questionnaires that can be useful in diagnosing neuropathic pain. It was initially written in French but immediately translated into English by the same team. The scale has been widely used since 2005 due to its simplicity. It evaluates neuropathic pain following central and peripheral neurological lesions. It is also used for diagnostic purposes, allowing the clinician to determine whether the pain is of neuropathic origin.This questionnaire has been well validated by a number of studies.
Time frame: At 3 months
Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire
Patient satisfaction with perioperative management will be evaluated using the EVAN-LR (Evaluation du Vécu de l'Anesthésie LocoRégionale = Assessment of the Experience of Locoregional Anesthesia) self-reported questionnaire. This questionnaire, which specifically assesses the satisfaction of patients undergoing regional anesthesia, comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. The consequences of staying alert during regional anesthesia are specifically addressed by two items.
Time frame: Day 0
Clinical or biological adverse events: Experimental group
All clinical or biological adverse events will be recorded on the electronic reporting form from Day 0 up to Day 2. These include bleeding, hematoma, rehospitalization, paresthesia, nausea and vomiting after removal of anesthesia.
Time frame: From Day 0 to Day 2
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Time frame: Day 0
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Time frame: Day 1
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Time frame: Day 2
Pain on a visual numerical scale : Control group
Pain will be evaluated on a visual numerical scale in the control group
Time frame: Day 7
Neuropathic pain according to the DN4 questionnaire: Control group
Pain in the control group will be evaluated by telephone using the DN4 questionnaire. This is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The DN4 (which stands for Douleur Neuropathique 4 i.e. Neuropathic Pain 4) is one of the questionnaires that can be useful in diagnosing neuropathic pain. It was initially written in French but immediately translated into English by the same team. The scale has been widely used since 2005 due to its simplicity. It evaluates neuropathic pain following central and peripheral neurological lesions. It is also used for diagnostic purposes, allowing the clinician to determine whether the pain is of neuropathic origin.This questionnaire has been well validated by a number of studies.
Time frame: At 3 months
Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group
Patient satisfaction with perioperative management will be evaluated using the EVAN-LR (Evaluation du Vécu de l'Anesthésie LocoRégionale = Assessment of the Experience of Locoregional Anesthesia) self-reported questionnaire. This questionnaire, which specifically assesses the satisfaction of patients undergoing regional anesthesia, comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. The consequences of staying alert during regional anesthesia are specifically addressed by two items.
Time frame: Day 0
Clinical or biological adverse events: Control group
All clinical or biological adverse events will be recorded on the electronic reporting form from Day 0 up to Day 2. These include bleeding, hematoma, rehospitalization, paresthesia, nausea and vomiting after removal of anesthesia.
Time frame: From Day 0 to Day 2
Sex of patients in the Experimental group
Male/Female
Time frame: Day 0
Age of patients in the Experimental group
In years
Time frame: Day 0
Weight of patients in the Experimental group
In kilograms
Time frame: Day 0
Height of patients in the Experimental group
In centimeters
Time frame: Day 0
Body Mass Index of patients in the Experimental group
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Time frame: Day 0
Sex of patients in the Control group
Male/Female
Time frame: Day 0
Age of patients in the Control group
In years
Time frame: Day 0
Weight of patients in the Control group
In kilograms
Time frame: Day 0
Height of patients in the Control group
In centimeters
Time frame: Day 0
Body Mass Index of patients in the Control group
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Time frame: Day 0
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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