Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks

The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively

Study Overview

• Status: Enrolling by invitation
• Conditions: Regional Anesthesia
• Intervention / Treatment: Other: External Oblique Intercostal Plane Block; Other: Caudal Block Anesthesia; Other: Erector Spinae Plane Block

Detailed Description

umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) Various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) Day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) This has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. Surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) External oblique intercostal plane block (EOIPB) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , LA is deposited into the fascial plane beneath the external oblique muscle (EOM) and superficial to the sixth rib or external intercostal muscle. It targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3)

Caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. Ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) The erector spinae plane block (ESPB), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 0020
    • Mohamed Zakarea Wfa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.

Exclusion Criteria:

• Parents refusal.
• Coagulopathy.
• Allergy to local anesthesia.
• Local infection at the site of injection.
• Neurological anomalies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group E; Erector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine bilaterally	Other: External Oblique Intercostal Plane Block; the needle will be advanced until the tip lay in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs
Active Comparator: Group C; Caudal block group will receive 1 ml/kg of 0.25% bupivacaine.	Other: Caudal Block Anesthesia; The needle will be advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament. Once the needle will be confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.
Active Comparator: Group EOI; External oblique intercostal block will recive 0.5 ml/kg 0.25 % bupivacaine bilaterally.	Other: Erector Spinae Plane Block; The correct location of the needle tip in the fascial plane deep to the erector spinae muscle will be confirmed by injecting 0.5-1 ml of saline and observing the fluid lifting the erector spinae muscle off the transverse process while avoiding muscle distension (hydro dissection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Faces Legs Activity Cry Consolability tool (FLACC, 0- 10)	15 minute after operation , 30 minutes after operation and 4 h after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome	First dose of fentanyl as a rescue analgesia in dose of 0.5 μg/kg. Total doses of fentanyl as a rescue analgesia.	6 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): August 10, 2025
• Study Completion (Estimated): September 10, 2025

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia; Hernia, Abdominal; Hernia, Ventral; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 36264PR1119/3/25

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