NCT04215614

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.

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 2020

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

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

December 29, 2019

Last Update Submit

April 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Block performance time

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

    Twenty minutes before surgery

Secondary Outcomes (1)

  • Visual analog pain score

    Postoperative 24 hours

Study Arms (2)

Group Lateral Sagittal

ACTIVE COMPARATOR

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

Drug: Lidocaine and Bupivacaine solutionDevice: Lateral Sagittal block

Group Costoclavicular

ACTIVE COMPARATOR

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

Drug: Lidocaine and Bupivacaine solutionDevice: Costoclavicular block

Interventions

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

Group CostoclavicularGroup Lateral Sagittal

Ultrasound-guided costoclavicular brachial plexus block

Group Costoclavicular

Ultrasound-guided lateral sagittal brachial plexus block

Group Lateral Sagittal

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30658327BACKGROUND
  • 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.

    PMID: 29923950BACKGROUND

MeSH Terms

Conditions

Hand InjuriesDiseaseForearm Injuries

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsArm Injuries

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

January 2, 2020

Primary Completion

April 3, 2020

Study Completion

April 10, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations