Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04855149
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2021-04-19
Brief Title:
Satisfaction Survey After Distal Surgery Performed Under Local Infiltration Walant or Under Axillary Block
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Satisfaction Survey After Distal Surgery Performed Under Local Infiltration Walant or Under Axillary Block
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WALAX
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None