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

NCT04855149 | Completed

• 1 other identifier: Local/2020/PC-01
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesiology; Satisfaction, Patient; Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

WALANT

anesthesia performed with WALANT technique

Other: Patient satisfaction

BAx

anesthesia performed with axillary block under ultrasound control

Other: Patient satisfaction

Interventions

Patient satisfaction OTHER

Patient satisfaction evaluated with EVAN LR questionnaire

BAx; WALANT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Philippe Cuvillon

  CHU NIMES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 20, 2021

Record last verified: 2021-04

Locations

FR (1)