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Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Primary Purpose

Hand Injuries and Disorders, Forearm Injuries

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Lidocaine and Bupivacaine solution

Costoclavicular block

Lateral Sagittal block

About this trial

This is an interventional treatment trial for Hand Injuries and Disorders

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group Lateral Sagittal

Group Costoclavicular

Arm Description

Ultrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine

Ultrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine

Outcomes

Primary Outcome Measures

Block performance time

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

Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Full Information

NCT ID

NCT04215614

First Posted

December 29, 2019

Last Updated

April 11, 2020

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT04215614

Brief Title

Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Official Title

The Comparison of Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

April 3, 2020 (Actual)

Study Completion Date

April 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Injuries and Disorders, Forearm Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group Lateral Sagittal

Arm Type

Active Comparator

Arm Description

Ultrasound-Guided lateral sagittal brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine

Arm Title

Group Costoclavicular

Arm Type

Active Comparator

Arm Description

Ultrasound-Guided costoclavicular brachial plexus block with 1:1 ratio 2% lidocaine, and 0.5% bupivacaine

Intervention Type

Drug

Intervention Name(s)

Lidocaine and Bupivacaine solution

Intervention Description

1:1 ratio 2% lidocaine, and 0.5% bupivacaine

Intervention Type

Device

Intervention Name(s)

Costoclavicular block

Intervention Description

Ultrasound-guided costoclavicular brachial plexus block

Intervention Type

Device

Intervention Name(s)

Lateral Sagittal block

Intervention Description

Ultrasound-guided lateral sagittal brachial plexus block

Primary Outcome Measure Information:

Title

Block performance time

Description

The time interval between the contact of the ultrasound probe to skin and end of local anesthetics injection.

Time Frame

Twenty minutes before surgery

Secondary Outcome Measure Information:

Title

Visual analog pain score

Description

Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Time Frame

Postoperative 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Ataturk University

City

Erzurum

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

30658327

Citation

Yayik AM, Cesur S, Ozturk 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. No abstract available.

Results Reference

background

PubMed Identifier

29923950

Citation

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.

Results Reference

background

Learn more about this trial

Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

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