NCT05187988

Brief Summary

In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

November 28, 2021

Last Update Submit

September 4, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Block success rate

    Investigator will compare success rate of both types of block and which one is more likely to be successfully administrated

    one year

  • Complications

    Investigators will compare complications like pneumothorax,nerve injury,bleeding and which one is more likely to cause complications

    one year

  • Duration of sensory and motor blockade

    Time which each procedure will take to block sensory and motor stimuli

    one year

Secondary Outcomes (2)

  • Duration of procedure

    one year

  • Number of needle passes

    one year

Study Arms (2)

Supraclavicular approach group

ACTIVE COMPARATOR

probe placed firmly over the supraclavicular fossa, parallel to the clavicle to obtain a short-axis view of the divisions of the brachial plexus and the subclavian artery, lying on the first rib After skin infiltration with lidocaine 2% a 23-gauge 70mm block needle inserted in-plane with the ultrasound beam, in a lateral-to-medial direction, until the needle tip's positioned at the junction of the first rib and subclavian artery

Procedure: supraclavicular brachial plexus block

Retroclavicular approach group

ACTIVE COMPARATOR

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 be then 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 is constantly seen, until it is positioned posterior to the axillary artery

Procedure: Retroclavicular brachial plexus block

Interventions

group will receive brachial plexus block above clavicle,Injection of anaesthetic will be done in brachial plexus around subclavian artery

Supraclavicular approach group

group will receive brachial plexus block inferior to the clavicle,injection of anaesthetic will be done around axillary artery

Retroclavicular approach group

Eligibility Criteria

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

You may qualify if:

  • patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

You may not qualify if:

  • Patient refusal .
  • local infection or deformity at the block site.
  • Patient with significant neurological , psychiatric or neuromuscular disease.
  • Pregnancy or lactating women .
  • Coagulopathy .
  • Morbid obesity .
  • History of allergy to local anaesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.

    PMID: 26670119BACKGROUND
  • Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193.

    PMID: 25478758BACKGROUND
  • Charbonneau J, Frechette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284.

    PMID: 26222346BACKGROUND
  • Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.

    PMID: 30857608BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at anasthesia department sohag university hospital

Study Record Dates

First Submitted

November 28, 2021

First Posted

January 12, 2022

Study Start

January 5, 2022

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations