NCT05240729

Brief Summary

Comparison of 3 approach of infraclavicular brachial plexus

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

February 6, 2022

Last Update Submit

January 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor and sensory block success rate

    Success rate 30 min after local anasthetic injections

    30 min

Study Arms (3)

Retroclavicular

ACTIVE COMPARATOR

Retroclavicular approach to the infraclavicular region, the probe will be placed below and perpendicular to the clavicle, in a paramedian sagittal plane, medial to the coracoid process, to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will then be inserted in the supraclavicular fossa, approximately 1 cm posteriorly to the clavicle, and advanced in plane and strictly parallel to the ultrasound transducer. After passing the initial blind zone of about 2 cm caused by the acoustic shadow of the clavicle, the needle tip will be constantly seen, until it will be positioned posterior to the axillary artery.

Procedure: Infraclavicular brachial plexus block

Costoclavicular

ACTIVE COMPARATOR

A new approach to the infraclavicular block The ultrasound transducer will be placed parallel and inferior to the clavicle and angled cephalad to optimize the ultrasound view. The block needle will be inserted in-plane from a lateral to medial direction into the costoclavicular space and the entire drug will be deposited in this location

Procedure: Infraclavicular brachial plexus block

Classic

ACTIVE COMPARATOR

Infraclavicular brachial plexus block (ICPB) ultrasound probe will be placed near the lower edge of the clavicle, and a transverse view of the subclavian artery and vein will be visualized. Using a needle guide, the needle will be advanced under real-time ultrasound guidance, and local anaesthetic will be injected near the subclavian artery, 15 mm medially and 15 mm laterally to the artery. The extent of sensory and motor block will be evaluated at 30 minutes after the injection

Procedure: Infraclavicular brachial plexus block

Interventions

Using ultrasound in 3different techniques of infraclavicular brachial plexus block

ClassicCostoclavicularRetroclavicular

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand

You may not qualify if:

  • patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facutly of Medicine

Minya, 61111, Egypt

Location

Study Officials

  • Jozef zekry, MD

    Minia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 6, 2022

First Posted

February 15, 2022

Study Start

May 24, 2021

Primary Completion

February 24, 2022

Study Completion

June 24, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations