Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04046744
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2019-08-05
Brief Title:
Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery
Sponsor:
CMC Ambroise Paré
Organization:
CMC Ambroise Paré
Study Overview
Official Title:
Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery
Status:
COMPLETED
Status Verified Date:
2022-09
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:
BAXASSO
Brief Summary:
Fractures of the forearm bones that occur around the wrist are common in the elderly Standard anesthesia for its surgical treatment is regional anesthesia RA supraclavicular block infraclavicular block or axillary block BAX However these techniques have some limitations such as the postoperative pain management and the non-specificity of the analgesia Indeed analgesia is not specific to the wrist and extends to the elbow and forearm preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic LA is used Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective good anesthesia for surgery and specific analgesia
The hypothesis of this study is that for the wrist surgery axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction an optimal surgical comfort a longer post-operative analgesia duration and a faster recovery from motor block
The hypothesis of this study is that for the wrist surgery axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction an optimal surgical comfort a longer post-operative analgesia duration and a faster recovery from motor block
Detailed Description:
This multicenter prospective randomized open-Label study compares two techniques
BAX usual technique Axillary brachial plexus block Axillary block with a long-acting LA Ropivacaine
BAX-Asso experimental technique Axillary brachial plexus block Axillary block with a short-acting local anesthetic Lidocaine Analgesic block at the elbow with a long-acting local anesthetic Ropivacaine Every block will be performed under Ultrasound BAX will be performed using a multi-injection technique at contact with median nM radial nR ulnar nU musculocutaneous nMC and medial antebrachial cutaneous nCMAB nerves 15-30 mL of LA will be injected
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow 3-7 mL of LA will be injected
BAX usual technique Axillary brachial plexus block Axillary block with a long-acting LA Ropivacaine
BAX-Asso experimental technique Axillary brachial plexus block Axillary block with a short-acting local anesthetic Lidocaine Analgesic block at the elbow with a long-acting local anesthetic Ropivacaine Every block will be performed under Ultrasound BAX will be performed using a multi-injection technique at contact with median nM radial nR ulnar nU musculocutaneous nMC and medial antebrachial cutaneous nCMAB nerves 15-30 mL of LA will be injected
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow 3-7 mL of LA will be injected
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