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Lateral Sagittal vs Costoclavicular Brachial Plexus Block in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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


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




Primary Outcome Measures :
  1. 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 :
  1. 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)



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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

Information from the National Library of Medicine

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
Publications:
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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