drugset / Trial / NCT05343299

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

NCT05343299

Phase 1 Completed 91 enrolled Nîmes University Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-05-30
Primary completion
2023-06-25
Completion
2023-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 50 mg Subcutaneous
Subject Lidocaine Other / unclassified 180 mg Subcutaneous
Subject Lidocaine Other / unclassified 200 mg Subcutaneous
Subject Ropivacaine Other / unclassified 15 mg Subcutaneous
Background Epinephrine Other / unclassified Subcutaneous

Indications

No indication recorded.