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

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction, Patient; Surgery; Anesthesiology
• Intervention / Treatment: Other: Patient satisfaction

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• France
  • Nimes, France, 30029
    • Chu de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients included in the study are patients at least 18 years old, hospitalized for scheduled surgery, who have accepted the principle of the study, are able to complete the EVAN-G questionnaire and are able to walk alone.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WALANT; anesthesia performed with WALANT technique	Other: Patient satisfaction; Patient satisfaction evaluated with EVAN LR questionnaire
BAx; anesthesia performed with axillary block under ultrasound control	Other: Patient satisfaction; Patient satisfaction evaluated with EVAN LR questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of day case surgery	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)	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Local/2020/PC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No