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

October 11, 2022 updated by: Ahmed Abdelaziz Ismail, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11562
        • Recruiting
        • Misr University for Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Serratus Anterior Plan block
The SAPB was performed in the operative room (OR) after anesthesia induction using the same ultrasound machine (SonoSite) and linear ultrasound transducer 8- 12 Hz. The patient was positioned in a lateral position with the operative side up and arm flexed forward; then, a linear ultrasound transducer was placed in a sagittal plane over the mid-clavicular line of the thoracic cage. Then, moving inferior-lateral direction till the fifth rib was identified in the mid-axillary line. The following structures were recognized: the rib, pleura, teres major muscle (superior), latissimus dorsi muscle (superficial and posterior), and serratus muscles muscle (deep and inferior). Under complete sterile conditions, a 22-gauge echogenic needle was introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle. Then, 0.4 ml/kg of 0.25% bupivacaine was injected with continuous ultrasound guidance.
Procedure: Fascial plane block
Serratus anterior plane block
Active Comparator: Erector spinae plane block
Patients in Group ESPB receive US erector spinae plane block by injecting 0.4ml/kg (bupivacaine 0.25%). Under strict aseptic precautions, The T3 spinous process is located by palpating and counting down from the C7 spinous process. A high-frequency 12 MHz linear ultrasound transducer is placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius (uppermost), rhomboids major (middle), and erector spinae (lowermost) will be identified superior to the hyperechoic transverse process.Using an in-plane approach a 22 G needle is inserted in caudal-cephalad direction until the tip is deep to erector spinae muscle. Correct needle tip location is confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread (i.e., hydrodissection) in the fascial plane between the erector spinae muscle and the transverse process. Then, bupivacaine is injected, and visualizing the fascial plane.
Procedure: Fascial plane block
Serratus anterior plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative fentanyl consumption
Time Frame: 9 month
amount of fentanyl in mic consumed in the 24 hours postoperatively
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative fentanyl consumption
Time Frame: 24 hours
total dose of fentanyl given during the surgical procedure
24 hours
FLACC score at 1,2,4,8,12,24 hours postoperatively
Time Frame: 24 hours

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
patient satisfaction
Time Frame: 24 hours
satisfaction in numeric scale from1 to 5. 1 express the worst, and 5 express the best.
24 hours
RASS score
Time Frame: 24 hours
sedation score
24 hours
time of first rescue analgesi
Time Frame: 24 hours
duration of postoperative analgesia
24 hours
Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
Time Frame: 24 hours
Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.
24 hours
PONV
Time Frame: 24 hours
post operative nausea and vomiting
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Misr University for Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N5098-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is a confidential issue according to the policy of my institute.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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