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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04215614
Other study ID # LS vs Costo BPB Pediatric
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date April 10, 2020

Study information

Verified date April 2020
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 10, 2020
Est. primary completion date April 3, 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility 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

Study Design


Intervention

Drug:
Lidocaine and Bupivacaine solution
1:1 ratio 2% lidocaine, and 0.5% bupivacaine
Device:
Costoclavicular block
Ultrasound-guided costoclavicular brachial plexus block
Lateral Sagittal block
Ultrasound-guided lateral sagittal brachial plexus block

Locations

Country Name City State
Turkey Ataturk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) Postoperative 24 hours
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