NCT04764591

Brief Summary

To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.

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 Jan 2022

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

February 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 10, 2021

Last Update Submit

February 8, 2024

Conditions

Keywords

lateral sagittal approachcostoclavicular approachblock successperfusion indexbrachial plexus

Outcome Measures

Primary Outcomes (2)

  • perfusion index

    the effect of the block on the perfusion index

    up to motor block scale ≥3

  • tissue oxygenation

    the effect of the block on the tissue oxygenation

    up to motor block scale ≥3

Secondary Outcomes (4)

  • motor block onset time

    Assessed 40 minutes after block completion

  • sensorial block onset time

    up to 24 hours

  • complications

    up to 24 hours

  • duration of block application

    during the intervention

Study Arms (2)

Lateral sagittal approach

ACTIVE COMPARATOR

Patients in this group will be randomized to receive a lateral sagittal approach for Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Other: Lateral sagittal approach

Costoclavicular approach

ACTIVE COMPARATOR

Patients in this group will be randomized to receive a costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Other: Costoclavicular approach

Interventions

Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block

Lateral sagittal approach

Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Costoclavicular approach

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
  • American Society of Anesthesiologists class 1 to 3
  • Ability to consent

You may not qualify if:

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (1)

  • Baytar C, Koksal BG. Effects of different approaches of infraclavicular brachial plexus block on perfusion index and tissue perfusion. Ann Med. 2025 Dec;57(1):2451765. doi: 10.1080/07853890.2025.2451765. Epub 2025 Jan 11.

Study Design

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

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 21, 2021

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations