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

Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy: A Randomized Controlled Stud

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

Study Overview

• Status: Completed
• Conditions: Thoracotomy; Ultrasound; Pediatrics; Post Operative Analgesia; Serratus Anterior Plane Block; Thoracic Erector Spinae Plane Block
• Intervention / Treatment: Drug: Control group; Drug: Serratus Anterior Plane Block (SAPB) group; Drug: Erector Spinae Plane Block (ESPB) group

Detailed Description

The incidence of diseases that requires thoracotomy is low in the pediatric age group. Thoracotomy is a severe burden on children and is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause retention of secretion, atelectasis, ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics.

The serratus anterior plane block (SAPB) has also recently become more popular options for post-thoracotomy analgesia. SAPB involves local anesthetic injection in a plane superficial or deep to the serratus anterior muscle; in both these locations, it blocks the lateral cutaneous branches of intercostal nerves.

The erector spinae plane block (ESPB) is an ultrasound-guided deep plane interfascial block defined by Forero in 2016. It has been shown to provide thoracic and abdominal analgesia. When injected at the T5 transverse process level, the local anesthetic spreads anteriorly through the thoracolumbar fascia and reaches the ventral and dorsal rami of the spinal nerves and posteriorly to the gray and white rami communicantes of the sympathetic chain, providing a C7 to T8 sensitive block. Although it was first described as a chronic pain block, there are increasingly reports about its use in postoperative acute pain.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients will receive general anesthesia alone	Drug: Control group; Patients will receive general anesthesia alone; Other Names: General anesthesia
Experimental: Serratus Anterior Plane Block (SAPB) group; 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; Patients will receive general anesthesia (GA) with ultrasound guided serratus anterior plane block 0.5 ml/kg 0.25% bupivacaine.; Other Names: General anesthesia (GA) with bupivacaine
Experimental: Erector Spinae Plane Block (ESPB) group; 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; Patients will receive general anesthesia (GA) with ultrasound guided erector spinae plane block 0.5 ml/kg 0.25% bupivacaine; Other Names: General anesthesia (GA) with bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 1st rescue analgesic requirement	Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated) was recorded.	24 hours postoperatively
Degree of pain	Pain was assessed after surgery over 24 hours using face, leg, activity, cry, consolability score (FLACC) score at following times: 0 (baseline), 1, 3, 6, 8, 12, and 24 h postoperative. FLACC score is used for pain assessment. (Face, legs, activity, cry and Consolability) is a measurement used to assess pain in children between age of 2 to 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maximum and we start to give rescue analgesia at score 4.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Aortic Diseases; Aneurysm; Perceptual Disorders; Aortic Dissection; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Anesthetics
• Other Study ID Numbers: 36264MS209/6/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No