Perioperative Analgesia Using Ultrasound Guided Erector Spinae Block vs Ultrasound Guided Caudal Block for Pain Control in Children Aged 2-7 Years Undergoing Lower Abdominal Surgery

December 1, 2025 updated by: Alexandria University

Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children

The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is:

Which block is more efficient in the perioperative period?

Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • EL Shatby
      • Alexandria, EL Shatby, Egypt
        • El Shatby University Hospital for Children

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 2-7 years old.
  • ASA I-II.
  • Elective surgery under general anaesthesia.
  • Lower abdominal surgery.

Exclusion Criteria:

  • Parent/caregiver refusal.
  • Allergy to one of the study medications.
  • Renal or cardiac disease.
  • Infection or redness at the site of injection.
  • Clinically significant coagulopathy.
  • Spinal anomalies.
  • Altered mental status.
  • Developmental delay.
  • Additional surgery at different surgical sites.
  • Block failure.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caudal Block Group
Patients who received ultrasound guided Caudal Block
Procedure: Caudal Block Anesthesia
Ukltrasound Guided Caudal Epidural Block
Active Comparator: Erector Spinae Plane Block Group
Patients who received ultrasound guided Erector Spinae Block
Procedure: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block
Ultrasound Guided Erector Spinae Plane block given bilaterally at level of L1.
Other Names:
  • Ultrasound Guided erector spinae pkane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.
Time Frame: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.

Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.

A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia.
At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to heart rate (beats/minute)
Time Frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery
Changes to heart rate (beats/minute) recorded before surgery, during surgery and immediately after surgery
T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery
The time to first rescue analgesic.
Time Frame: from 0 to 8 hours after block administration
Time from block administration to the patient's first requirement for rescue analgesia.
from 0 to 8 hours after block administration
Total postoperative analgesic requirements.
Time Frame: from 0 to 8 hours after block administration
Amount and frequency of analgesia patient requested
from 0 to 8 hours after block administration
Parent satisfaction with a 5-point Likert scale questionnaire.
Time Frame: At 8 hours after block administration
Parent or caregiver satisfaction about block efficiency on a scale of 1 to 5.
At 8 hours after block administration
Number of patients required rescue analgesic postoperatively.
Time Frame: From 0 to 8 hours after surgery.
Number of patiebts of asked for rescue analgesia is recorded.
From 0 to 8 hours after surgery.
Time to Modified Aldrete score ≥9.
Time Frame: from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes)
Postoperative recovery was assessed using the Modified Aldrete Scoring System, which evaluates five physiological criteria: activity, respiration, circulation, consciousness, and oxygen saturation
from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes)
Incidence of any adverse effects.
Time Frame: from end of surgery (0 hours) to 8 hours postoperatively
Any side effects reported by the patient related to analgesia.
from end of surgery (0 hours) to 8 hours postoperatively
Changes to mean arterial pressure (MAP)
Time Frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery
changes to mean arterial pressure (MAP) (mmHg) before surgery, during surgery and immediately after surgey
T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery
Changes to oxygen saturation
Time Frame: T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery
Changes to oxygen saturation before surgery, during surgery and immediately after surgery.
T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Study Chair: Ashraf A Abdelhalim, Doctorate, Professor of Anesethia and Surgical Intensive Care.
  • Study Director: Ahmed M El Attar, Doctorate, Professor of Anesethia and Surgical Intensive Care.
  • Study Director: Aliaa R Abdel Aziz, Doctorate, Assistant Professor of Anesethia and Surgical Intensive Care.

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)

May 1, 2024

Primary Completion (Actual)

August 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9250511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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