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

NCT ID: NCT04855149

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 202 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

WALANT

anesthesia performed with WALANT technique

Patient satisfaction

Intervention Type: OTHER

Patient satisfaction evaluated with EVAN LR questionnaire

BAx

anesthesia performed with axillary block under ultrasound control

Patient satisfaction

Intervention Type: OTHER

Patient satisfaction evaluated with EVAN LR questionnaire

Interventions

Patient satisfaction

Patient satisfaction evaluated with EVAN LR questionnaire

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Cuvillon

Role: PRINCIPAL_INVESTIGATOR

CHU NIMES

Locations

CHU de NIMES

Nîmes, , France

Countries

France

Other Identifiers

Local/2020/PC-01

Identifier Type: -

Identifier Source: org_study_id