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

Surgery Clinical Trial

— WALAX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04855149
• Other study ID #: Local/2020/PC-01
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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Related Conditions & MeSH terms

• Anesthesiology
• Satisfaction, Patient
• Surgery

Intervention

Other:
• Patient satisfaction
Patient satisfaction evaluated with EVAN LR questionnaire

Locations

Country	Name	City	State
France	CHU de NIMES	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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