PI and Tissue Perfusion for Different Approaches of Brachial Plexus Block

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT04764591

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Extremity Fracture Regional Anesthesia Brachial Plexus Blocks Perfusion Index Tissue Perfusion	Other: Lateral sagittal approach Other: Costoclavicular approach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Effect of Different Approaches of Infraclavicular Brachial Plexus Block on Perfusion Index and Tissue Perfusion: A Randomized Controlled Trial

Actual Study Start Date :

Dec 16, 2020

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lateral sagittal approach 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 Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block
Active Comparator: Costoclavicular approach Patients in this group will be randomized to receive a costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .	Other: Costoclavicular approach Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Arm

Intervention/Treatment

Active Comparator: Lateral sagittal approach

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

Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block

Active Comparator: Costoclavicular approach

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

Other: Costoclavicular approach

Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Outcome Measures

Primary Outcome Measures

perfusion index [up to motor block scale ≥3]
the effect of the block on the perfusion index
tissue oxygenation [up to motor block scale ≥3]
the effect of the block on the tissue oxygenation

Secondary Outcome Measures

motor block onset time [Assessed 40 minutes after block completion]
quality of motor block scale ≥2
sensorial block onset time [up to 24 hours]
quality of sensorial block scale ≥2
complications [up to 24 hours]
block related complications such as pneumothorax, vascular injury, local anesthetic systemic toxicity
duration of block application [during the intervention]
from the needle puncture to the end of the local anesthetic injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu	Turkey	67600

Sponsors and Collaborators

Zonguldak Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Çağdaş Baytar, assistant professor dr, Zonguldak Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT04764591

Other Study ID Numbers:

2020/24-10

First Posted:

Feb 21, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Çağdaş Baytar, assistant professor dr, Zonguldak Bulent Ecevit University

lateral sagittal approach

costoclavicular approach

block success

perfusion index

brachial plexus

Study Results

No Results Posted as of Mar 2, 2022