A Comparative Study Between Infraclavicular and Axillary Blocks for Assessment of Motor Power Using Handgrip Dynamometer

NCT05325372 | Completed

• 1 other identifier: MS-529-2021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Hand Surgery is surgery of the hand, the wrist, and the peripheral nerves of the upper limb. Many different types of surgeries can be performed on the hand, depending on the underlying cause of the problem such as Closed reduction and fixation, Tendon repair, Skin grafts, Skin flaps, Carpal Tunnel Release, and ganglion removal. Hand surgery is usually associated with marked postoperative pain. Ultrasound-guided regional anesthesia is usually performed in patients undergoing hand surgery. This study aims to compare Ultrasound-guided infraclavicular block and axillary block and assess the degree of motor power and duration by testing hand grip strength using a hydraulic hand dynamometer in patients undergoing hand surgery. Objectives: To determine the degree of a motor block using a hydraulic hand dynamometer. To Estimate time needed to regain full motor activity. To identify whether ultrasound-guided axillary block may preserve motor function to a greater extent than infraclavicular blocks.

Conditions

Hand Surgery; Ultrasound Guided

Outcome Measures

Primary Outcomes (1)

• Postoperative change in handgrip strength in the operative limb

  Postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength at 90 min from the block (%)

  it will be measured at 90 min from the block

Secondary Outcomes (1)

• Block related complications

  it will be measured in the first 24 hours postoperative

Study Arms (2)

Ultrasound guided axillary block

EXPERIMENTAL

the Ultrasound probe with a linear high frequency (8-14 MHZ) transducer will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles. Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe. The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. A local anesthetic will be administered adjacent to each of the four nerves (at least 5 ml for each).

Procedure: axillary block

Ultrasound guided infraclavicular block block

EXPERIMENTAL

The transducer is positioned in the parasagittal plane to identify the axillary artery. Surrounding the artery are the three cords of the brachial plexus: the lateral, posterior, and medial cords. The needle is inserted in-plane short-axis technique from the cephalad end of the probe, with the insertion point just inferior to the clavicle. A local anesthetic will be injected posterior to the axillary artery to achieve a U-shaped distribution around the artery (cephalad, caudad, and posterior).

Procedure: infraclavicular block

Interventions

axillary block PROCEDURE

it will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).

Also known as: peripheral nerve block

Ultrasound guided axillary block

infraclavicular block PROCEDURE

it will be given using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).

Also known as: peripheral nerve block

Ultrasound guided infraclavicular block block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender both males and females
• ASA Class I, II
• Age 18-60 years
• Patients undergoing minor hand surgery (skin graft, Carpal Tunnel Release, ganglion removal, and lipoma ) expected surgical time of more than 15 min and less than one hour.

You may not qualify if:

• Allergy to local anesthetic
• Infection of the skin at the site of block.
• Bilateral surgery, neck and clavicle deformities, existing neurological disease chronic pain diagnosis, pre-existing nerve damage, muscle injuries, and tendon injury.
• Coagulopathy, previous surgery on the operative limb, inability to comprehend study-related procedures, and clinically significant cognitive impairment.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Cairo University: collaborator

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, 202, Egypt

Location

Study Officials

• Yasser EL Halafawy, professor

  Anesthesia department , Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer-generated numbers and concealed by serially numbered, opaque, and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in a set of sealed envelopes each bearing only the case number on the outside. This study will be performed by 3 anesthetists; one anesthetist who is experienced in performing the blocks will be allocated to perform either the axillary or infraclavicular block according to a computer-generated sequence of random numbers and sealed envelope, and the other two anesthetists will be blinded to the technique performed, and they will monitor the patients intra and postoperatively. Assessment of brachial plexus blockade will be carried out every 10 mins until 30 min by one of these two blinded observers. The infraclavicular and axillary areas will be covered to maintain the blinding of investigators.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia (principal investigator)

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 15, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)