- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343299
Postoperative Experience of 2 WALANT-type Modes of Anesthesia Used in Ambulatory Surgery of the Upper Limb. (ROPIWA)
Evaluation of Postoperative Experience of Two WALANT-type Modes of Anesthesia (Lidocaine Alone or Combined With Ropivacaine) Used in Ambulatory Surgery of the Upper Limb. A Single-center Prospective Randomized, Single-blind Study
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029
- Yann GRICOURT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient eligible for outpatient surgery under WALANT for:
- Hand surgery such as carpal tunnel, stub finger, Dupuytren's disease;
- Elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome.
- Patient with free and informed consent.
- Patient with signed consent form.
- Patient affiliated to or beneficiary of a health insurance plan.
Exclusion Criteria:
- Ischemic vascular disorders such as severe Raynaud's disease, Buerger's disease, diabetic microangiopathy.
- Scleroderma.
- Known allergy to ropivacaine or lidocaine and possibility of cross-allergy with other amide-bound local cross-allergy with other local anesthetics with amide linkage.
- Severe hepatic impairment
- Acute porphyria.
- Intravascular anesthesia.
- Anesthesia by local infiltration in the extremities
- Coronary insufficiency.
- Ventricular rhythm disorders.
- Severe arterial hypertension.
- Obstructive cardiomyopathy.
- Hyperthyroidism.
- Hypovolemia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients undergoing hand surgery with a combination of lidocaine and ropivacaine
Patients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
|
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
Other Names:
|
Active Comparator: Patients undergoing hand surgery with lidocaine alone
Patients undergoing Wide Awake Local Anesthesia No Tourniquet -type hand surgery with lidocaine
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experimental group: experience of patients in the Lidocaine + Ropivacaine group
Time Frame: 48 hours after surgery
|
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. |
48 hours after surgery
|
Control group: experience of patients in the Lidocaine alone group
Time Frame: 48 hours after surgery
|
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. |
48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on a numerical visual analog scale : Experimental group
Time Frame: Day 0
|
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. |
Day 0
|
Pain on a numerical visual analog scale : Experimental group
Time Frame: Day 1
|
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. |
Day 1
|
Pain on a numerical visual analog scale : Experimental group
Time Frame: Day 2
|
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. |
Day 2
|
Pain on a numerical visual analog scale : Experimental group
Time Frame: Day 7
|
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. |
Day 7
|
Neuropathic pain according to the DN4 questionnaire: Experimental group
Time Frame: At 3 months
|
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.
|
At 3 months
|
Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire
Time Frame: Day 0
|
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.
|
Day 0
|
Clinical or biological adverse events: Experimental group
Time Frame: From Day 0 to Day 2
|
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.
|
From Day 0 to Day 2
|
Pain on a visual numerical scale : Control group
Time Frame: Day 0
|
Pain will be evaluated on a visual numerical scale in the control group
|
Day 0
|
Pain on a visual numerical scale : Control group
Time Frame: Day 1
|
Pain will be evaluated on a visual numerical scale in the control group
|
Day 1
|
Pain on a visual numerical scale : Control group
Time Frame: Day 2
|
Pain will be evaluated on a visual numerical scale in the control group
|
Day 2
|
Pain on a visual numerical scale : Control group
Time Frame: Day 7
|
Pain will be evaluated on a visual numerical scale in the control group
|
Day 7
|
Neuropathic pain according to the DN4 questionnaire: Control group
Time Frame: At 3 months
|
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.
|
At 3 months
|
Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group
Time Frame: Day 0
|
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.
|
Day 0
|
Clinical or biological adverse events: Control group
Time Frame: From Day 0 to Day 2
|
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.
|
From Day 0 to Day 2
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex of patients in the Experimental group
Time Frame: Day 0
|
Male/Female
|
Day 0
|
Age of patients in the Experimental group
Time Frame: Day 0
|
In years
|
Day 0
|
Weight of patients in the Experimental group
Time Frame: Day 0
|
In kilograms
|
Day 0
|
Height of patients in the Experimental group
Time Frame: Day 0
|
In centimeters
|
Day 0
|
Body Mass Index of patients in the Experimental group
Time Frame: Day 0
|
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
|
Day 0
|
Sex of patients in the Control group
Time Frame: Day 0
|
Male/Female
|
Day 0
|
Age of patients in the Control group
Time Frame: Day 0
|
In years
|
Day 0
|
Weight of patients in the Control group
Time Frame: Day 0
|
In kilograms
|
Day 0
|
Height of patients in the Control group
Time Frame: Day 0
|
In centimeters
|
Day 0
|
Body Mass Index of patients in the Control group
Time Frame: Day 0
|
BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
|
Day 0
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics
- Lidocaine
- Ropivacaine
Other Study ID Numbers
- NIMAO/2021-1/YG-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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