Clinical trial NCT04855149: Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block
Official title: Satisfaction Survey After Distal Surgery Performed Under Local Infiltration (Walant) or Under Axillary Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesiology
Satisfaction, Patient
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

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Primary outcomes:
measure: Satisfaction of day case surgery
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: CHU NIMES
name: Philippe Cuvillon
role: PRINCIPAL_INVESTIGATOR
References: