Anesthesia, Local Clinical Trial
— ROPIWAOfficial 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
Verified date | November 2023 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Yann GRICOURT | Nîmes | Gard |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
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 |
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