Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

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ClinicalTrials.gov Identifier: NCT04215614

Recruitment Status : Completed

First Posted : January 2, 2020

Last Update Posted : April 14, 2020

Sponsor:

Information provided by (Responsible Party):

Ahmet Murat Yayik, Ataturk University

Study Description

Brief Summary:

Costoclavicular approach has lots of advantages compared to the lateral sagittal approach for infraclavicular brachial plexus block. Although the efficacy of this block has been demonstrated in adults, there are no randomized controlled trials in the literature on the application of pediatric patients. Our aim was to compare the ultrasound-guided infraclavicular and costoclavicular approach in pediatric patients.

Condition or disease	Intervention/treatment	Phase
Hand Injuries and Disorders Forearm Injuries	Drug: Lidocaine and Bupivacaine solution Device: Costoclavicular block Device: Lateral Sagittal block	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children
Actual Study Start Date :	January 2, 2020
Actual Primary Completion Date :	April 3, 2020
Actual Study Completion Date :	April 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine Bupivacaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group Lateral Sagittal Ultrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine	Drug: Lidocaine and Bupivacaine solution 1:1 ratio 2% lidocaine, and 0.5% bupivacaine Device: Lateral Sagittal block Ultrasound-guided lateral sagittal brachial plexus block
Active Comparator: Group Costoclavicular Ultrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine	Drug: Lidocaine and Bupivacaine solution 1:1 ratio 2% lidocaine, and 0.5% bupivacaine Device: Costoclavicular block Ultrasound-guided costoclavicular brachial plexus block

Outcome Measures

Primary Outcome Measures :

Block performance time [ Time Frame: Twenty minutes before surgery ]
The time interval between the contact of the ultrasound probe to skin and end of local anesthetics injection.

Secondary Outcome Measures :

Visual analog pain score [ Time Frame: Postoperative 24 hours ]
Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-II patients
Patients who will undergo hand or forearm surgery

Exclusion Criteria:

Infection in the area to be injected
Coagulopathy,
Previously known neurological damage

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215614

Locations

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Turkey
Ataturk University
Erzurum, Turkey

Sponsors and Collaborators

Ataturk University

More Information

Publications:

Yayik AM, Cesur S, Öztürk F, Celik EC, Ahiskalioglu A. Ultrasound guided costoclavicular approach to brachial plexus: First pediatric report. J Clin Anesth. 2019 Aug;55:136-137. doi: 10.1016/j.jclinane.2019.01.008. Epub 2019 Jan 15.

Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.

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Responsible Party:	Ahmet Murat Yayik, Assistant Professor, Ataturk University
ClinicalTrials.gov Identifier:	NCT04215614
Other Study ID Numbers:	LS vs Costo BPB Pediatric
First Posted:	January 2, 2020 Key Record Dates
Last Update Posted:	April 14, 2020
Last Verified:	April 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Wounds and Injuries Hand Injuries Forearm Injuries Arm Injuries Lidocaine Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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