Postoperative Experience of 2 WALANT-type Modes of Anesthesia Used in Ambulatory Surgery of the Upper Limb.

Anesthesia, Local Clinical Trial

— ROPIWA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343299
• Other study ID #: NIMAO/2021-1/YG-01
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2022
• Est. completion date: September 25, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Elbow Surgery
• Hand Surgery
• Wrist Surgery

Intervention

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.
• Ambulatory surgery under a combination of Lidocaine and Ropivacaine
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

Locations

Country	Name	City	State
France	Yann GRICOURT	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex of patients in the Experimental group	Male/Female	Day 0
Other	Age of patients in the Experimental group	In years	Day 0
Other	Weight of patients in the Experimental group	In kilograms	Day 0
Other	Height of patients in the Experimental group	In centimeters	Day 0
Other	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.	Day 0
Other	Sex of patients in the Control group	Male/Female	Day 0
Other	Age of patients in the Control group	In years	Day 0
Other	Weight of patients in the Control group	In kilograms	Day 0
Other	Height of patients in the Control group	In centimeters	Day 0
Other	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.	Day 0
Primary	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.	48 hours after surgery
Primary	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.	48 hours after surgery
Secondary	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.	Day 0
Secondary	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.	Day 1
Secondary	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.	Day 2
Secondary	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.	Day 7
Secondary	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.	At 3 months
Secondary	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.	Day 0
Secondary	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.	From Day 0 to Day 2
Secondary	Pain on a visual numerical scale : Control group	Pain will be evaluated on a visual numerical scale in the control group	Day 0
Secondary	Pain on a visual numerical scale : Control group	Pain will be evaluated on a visual numerical scale in the control group	Day 1
Secondary	Pain on a visual numerical scale : Control group	Pain will be evaluated on a visual numerical scale in the control group	Day 2
Secondary	Pain on a visual numerical scale : Control group	Pain will be evaluated on a visual numerical scale in the control group	Day 7
Secondary	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.	At 3 months
Secondary	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.	Day 0
Secondary	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.	From Day 0 to Day 2