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Hand SurgeryNCT05325372

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

A study testing axillary block and infraclavicular block in people with Hand Surgery and Ultrasound Guided, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hand Surgery, Ultrasound Guided
What is being tested?
axillary block and infraclavicular block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteEgypt
Study dates
15 Apr 2022to 26 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy, Cairo University

    Cairo, 202

Other trials in Egypt

About this study

Official title: A Comparative Study Between the Ultrasound-guided Infraclavicular Block and Axillary Block for Assessment of Motor Power Degree and Duration Using Handgrip Dynamometer in Patients Undergoing Minor Hand Surgery. A Randomized Control Trial

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.

Read more

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.

Read the detailed description

This randomized control trial is designed to include (52) patients ASA physical status I, II patients ranging from(18) to(60)years old scheduled for hand surgery

Patients meeting the inclusion criteria will be randomly assigned to receive either:

Group I: axillary block technique (n=26) (group A) GroupII: infraclavicular block technique( n=26)(group B) Anesthesia management After arrival to the anesthetic room, An 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry) while performing the block and throughout the surgical procedure. Premedication will be given intravenously in the form of 0.03 mg/kg midazolam. 1 g paracetamol iv will be given for all patients Under aseptic conditions, a preliminary scan will be performed using siemens acuson x 300 ultrasound with 8-14 MHz linear transducer. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany) All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine (10 ml 0.5% bupivacaine + 10 ml normal saline).

Axillary block

Patients in group A will be placed in the supine position with the arm to be blocked abducted and externally rotated. After sterilization of the axilla, 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).

Infraclavicular block

Patients in group B will be placed in the supine position with the head turned away from the side to be blocked. The arm is abducted to 90 degrees and the elbow flexed. the skin is disinfected and 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).

Injection of 5 ml lidocaine 2% will be also used in all patients to eliminate tourniquet pain and pain in the area of distribution of intercostobrachial nerve in case of use of a tourniquet

Block assessment

After completion of all block procedures. A formal assessment of block efficacy will be performed by an independent observer who will be masked to each subject's group allocation every 10 min after needle removal for 30 min. surgery will be started once surgical anesthesia will be achieved at any time point or until 30 min had elapsed. if surgical anesthesia will not be achieved at 30 min the block will be considered failed and general anesthesia will proceed.

Sensory blockade of the musculocutaneous, median, radial and ulnar nerves will be graded according to the previously validated 3 point scale using a cold test: respectively: 0 = no perception, 1 = decreased sensation, or 2 = normal sensation. A successful blockade is defined as a complete sensory blockade (i.e., sensory block score = 0) within 30 minutes of completing the block. If complete sensory blockade will not be achieved within 30 minutes, the affected subject will be excluded from the study and categorized as a block failure. The subject was offered a supplementary nerve block if there is sufficient time before surgery, or general anesthesia will be proceeded to achieve surgical anesthesia.

The procedural time (seconds) for each block will be recorded. This duration is defined as the interval from the ultrasound transducer's first contact with the subject to the time the block needle exit the skin. Block onset time will be recorded (from a completed injection of local anesthetic until loss of cold sensation) Duration of the block will be recorded, defined as the time from completing injection of the local anesthetic till complete recovery of sensory function, i.e., the cold test will be assessed every 30 min in the postoperative period till patient feel the cold sensation

The motor blockade will be assessed by testing patients' handgrip strength using a hydraulic handgrip dynamometer, baseline measurements will be recorded on both the ipsilateral and contralateral sides. hand grip strength will be measured preoperative, 30 min from a block, and after surgery. postoperative change in handgrip strength in the operative limb as a percent reduction of preoperative baseline strength will be measured. The time needed to regain full motor power will be measured.

All patients will be postoperatively monitored in the post-anesthesia care unit (PACU) for 1 h and thereafter discharged to their wards. Post-operative pain at the incision site will be assessed by visual analog scale (VAS) and a score of more than 3 when recorded will be taken as an endpoint for the duration of block and the patient was given supplementary analgesics i.e. Inj. Diclofenac Sodium 1-1.5 mg/kg intramuscular. Subject satisfaction will be assessed with a standardized question scored on a seven-point Likert scale: "Thinking about your nerve blocks, how satisfied were you with them: where 1 is not at all, 4 is neutral, and 7 is completely satisfied?"

Block related complications will be recorded such as failed block, motor weakness 24 h after the block local anesthetic toxicity, vascular puncture, paraesthesia, and pneumothorax.

Being tested
axillary block, infraclavicular block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • axillary blockProcedure or surgery

    Also called peripheral nerve block

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

  • infraclavicular blockProcedure or surgery

    Also called peripheral nerve block

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

Study groups in NCT05325372
Study groupRoleWhat they receive
Ultrasound guided axillary blockExperimentalthe 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).
Receives: Procedure: axillary block
Ultrasound guided infraclavicular block blockExperimentalThe 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).
Receives: Procedure: infraclavicular block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (%)

    Measured: it will be measured at 90 min from the block

Secondary outcomes (1)
  1. Block related complications

    local anesthetic toxicity, vascular puncture, paresthesia, and pneumothorax

    Measured: it will be measured in the first 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study start15 Apr 2022
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325372
Sponsor's protocol ID
MS-529-2021
Status last verified
Apr 2023
First submitted
6 Apr 2022
Last updated
28 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing axillary block and infraclavicular block in people with Hand Surgery and Ultrasound Guided, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative change in handgrip strength in the operative limb (time frame: it will be measured at 90 min from the block). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.

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