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NCT04933877 Clinical Trial

Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients

Anesthesia Clinical Trial

Official title:
Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04933877
Other study ID # N5098-2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date April 2023

Study information
Verified date October 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility Inclusion Criteria - Age 1 to 10-year-old - ASA I, II, and II Exclusion Criteria - Patients whose parents or legal guardians refusing to participate. - Preoperative mechanical ventilation. - Preoperative inotropic drug infusion. - Known or suspected coagulopathy.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fascial plane block
Serratus anterior plane block

Locations
Country Name City State
Egypt Misr University For Science And Technology Giza

Sponsors (2)
Lead Sponsor Collaborator
Cairo University Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi — View Citation

Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary post-operative fentanyl consumption amount of fentanyl in mic consumed in the 24 hours postoperatively 9 month
Secondary intraoperative fentanyl consumption total dose of fentanyl given during the surgical procedure 24 hours
Secondary FLACC score at 1,2,4,8,12,24 hours postoperatively FLACC score ( Face Leg Activity Cry Consolability ) it is pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.
each point is given score between 0 and 2. the maximum score is 10 the lowest is 0		 24 hours
Secondary patient satisfaction satisfaction in numeric scale from1 to 5. 1 express the worst, and 5 express the best. 24 hours
Secondary RASS score sedation score 24 hours
Secondary time of first rescue analgesi duration of postoperative analgesia 24 hours
Secondary Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively. Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively. 24 hours
Secondary PONV post operative nausea and vomiting 24 hours
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