Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block.

NCT04053491 | Withdrawn

• 1 other identifier: CHUBX 2019/04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.

Conditions

Anesthesia, Regional; Brachial Plexus Block

Keywords

Hand surgery; Anesthesia, Regional; Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• Anesthesia score

  Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand

  24 hours after block realization

Secondary Outcomes (9)

• Duration of catheter insertion procedure

  During block realization

• Maximal pain during the surgery procedure

  During surgery

• Maximal pain during the first 24 hours

  During the first 24 hours after block realization

• Anesthesia score

  30 minutes after block realization

• Anesthesia score

  48 hours after block realization

Study Arms (2)

Axillary block group

EXPERIMENTAL

Initial bolus will be given and then a perinervous catheter will be inserted by the axillary approach.

Procedure: Hand surgery under regional anesthesia

Infraclavicular block group

EXPERIMENTAL

Initial bolus will be given and then a perinervous catheter will be inserted by the infraclavicular approach.

Procedure: Hand surgery under regional anesthesia

Interventions

Hand surgery under regional anesthesia PROCEDURE

In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.

Axillary block group; Infraclavicular block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with a social insurance number
• ASA 1-3
• Patients undergoing hand surgery requiring a continuous brachial plexus block
• Elective or urgent surgery
• Effective contraception (HAS criteria)
• Informed consent

You may not qualify if:

• Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
• Preexisting neuropathy
• Pregnancy
• Arteriovenous fistula
• Obesity (BMI \>40)
• Another surgical site implicated during the surgery
• Incapacity to abduct the operated arm
• Preoperative use of morphine or equivalent

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 12, 2019
• Study Start: September 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share