Clinical trial

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

Name
NIMAO/2021-1/YG-01
Description
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.
Trial arms
Trial start
2022-05-30
Estimated PCD
2023-06-25
Trial end
2023-09-25
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Patients undergoing hand surgery with lidocaine alone
Other names:
Local anesthesia with lidocaine alone
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
Arms:
Patients undergoing hand surgery with a combination of lidocaine and ropivacaine
Other names:
Local anesthesia with lidocaine and ropivacaine
Size
91
Primary endpoint
Experimental group: experience of patients in the Lidocaine + Ropivacaine group
48 hours after surgery
Control group: experience of patients in the Lidocaine alone group
48 hours after surgery
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-center, prospective, randomized, single-blind superiority study comparing two management modalities in WALANT-type anesthesia for ambulatory hand surgery: addition of ropivacaine to lidocaine (experimental group) versus lidocaine alone (control group).\n\nJardé Law Research Involving Human Persons category 1', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The patient will be blinded to his or her anesthesia protocol. The investigating physician who performs the anesthesia and surgery will be different from the evaluators (IDE, hospital CRA, evaluating physician) who will be blinded to the patient's assignment group.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 91, 'type': 'ACTUAL'}}
Updated at
2023-11-27

1 organization

2 products

5 indications

Product
Lidocaine
Indication
Anesthesia
Indication
Local
Indication
Hand Surgery
Indication
Wrist Surgery
Indication
Elbow Surgery