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Clinical Trials/NCT04855149
NCT04855149
Completed
Not Applicable

Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block

Centre Hospitalier Universitaire de Nīmes1 site in 1 country202 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesiology
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
202
Locations
1
Primary Endpoint
Satisfaction of day case surgery
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

In the 1970s-1980s, Dr. Donald Lalonde (surgeon, Canada) developed an anesthetic technique for hand surgery called WALANT (Wide Awake Local Anesthesia No Tourniquet). This technique is based on the joint administration of a local anesthetic (lidocaine) and epinephrine (adrenaline), which limits bleeding and makes it possible to dispense with a tourniquet. In addition, and contrary to truncal anesthesia, this combination of drugs infiltrated opposite the surgical site preserves the mobility of the limb. However, this technique is not without risk and some adverses events have been reported: intoxication by local anesthetics due to overdose and digital necrosis with the use of procaine or cocaine.

Currently in France, truncal anesthesia with a pneumatic tourniquet on the arm is often preferred for hand surgery (axillary block or BAx). In this case, the pneumatic tourniquet is used to minimize intraoperative blood loss and improve the visibility of the operating field. However, it can be a source of discomfort, pain, or transient neurological deficit.

To date, few studies comparing WALANT and BAx are available and none have evaluated the perioperative experience of patients and the incidence of paresthesias in the short and long term.

In order to measure the perioperative satisfaction of patients undergoing hand surgery with BAx or WALANT, we conduct a prospective observational non-randomized study evaluating the EVAN-LR satisfaction score at D0. The secondary objectives of the study are to evaluate postoperative adverse events (digital necrosis, paresthesias, local anesthetic intoxications, infection of the operated limb), consumption of postoperative analgesic treatments in both groups.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
December 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 yars
  • scheduled surgery of the hand, wrist or elbow under local or loco-regional anesthesia
  • Consent to participate

Exclusion Criteria

  • contraindication to loco-regional or local anesthesia
  • allergy to the products administered (lidocaine, epinephrine)
  • pregnant woman
  • comprehension disorder (confusion, cognitive disorder...) or linguistic disorder that does not allow answering the follow-up questionnaires
  • refusal to participate or to follow up
  • surgery in emergency or under general anesthesia
  • Translated with www.DeepL.com/Translator (free version)

Outcomes

Primary Outcomes

Satisfaction of day case surgery

Time Frame: Day 0

Satisfaction of day case surgery measured with EVAN LR score (EVAN LR : Evaluation du Vécu de l'Anesthésie LocoRégionale; the EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain; , All dimensions are scored on a scale from 0 to 100, with 100 indicating the best possible level of satisfaction and 0 the worst)

Study Sites (1)

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