Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy

NCT06862518 | Completed

• 1 other identifier: 36264MS209/6/23
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the post operative analgesic effect of serratus anterior plane block versus thoracic erector spinae plane block in pediatrics undergoing thoracotomy

Conditions

Ultrasound; Serratus Anterior Plane Block; Thoracic Erector Spinae Plane Block; Post Operative Analgesia; Pediatrics; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Total rescue analgesia consumption

  Rescue analgesia is planned based on the patients' face, leg, activity, cry, consolability score (FLACC) scores. Morphine 0.05 mg/kg IV was given as rescue analgesia in the case of FLACC scores above 3.The analgesic requirements in the first 24 h postoperatively were recorded.

  24 hours postoperatively

Secondary Outcomes (2)

• Time to 1st rescue analgesic requirement

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients will receive general anesthesia alone

Drug: Control group

Serratus Anterior Plane Block (SAPB) group

EXPERIMENTAL

Patients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine.

Drug: Serratus Anterior Plane Block (SAPB) group

Erector Spinae Plane Block (ESPB) group

EXPERIMENTAL

Patients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine.

Drug: Erector Spinae Plane Block (ESPB) group

Interventions

Control group DRUG

Patients will receive general anesthesia alone

Also known as: General anesthesia

Control group

Serratus Anterior Plane Block (SAPB) group DRUG

Patients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine.

Also known as: General anesthesia (GA) with bupivacaine

Serratus Anterior Plane Block (SAPB) group

Erector Spinae Plane Block (ESPB) group DRUG

Patients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine

Also known as: General anesthesia (GA) with bupivacaine

Erector Spinae Plane Block (ESPB) group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient aged between 2 and 7 years.
• Patient posted for the right or left thoracotomy under general anesthesia.

You may not qualify if:

• Parents who refuse regional anesthesia.
• Children who had any coagulation abnormality.
• Deformity of the thoracolumbar spine.
• Infection at the site of injection.
• History of allergy to the local anesthetics.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Control Groups; Anesthesia, General; Saposins; Population Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anesthesia; Anesthesia and Analgesia; Sphingolipid Activator Proteins; Coenzymes; Enzymes and Coenzymes; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)