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

NCT ID: NCT06948253

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-09-10

Brief Summary

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

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)

Conditions

Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group E

Erector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine bilaterally

Group Type: ACTIVE_COMPARATOR

External Oblique Intercostal Plane Block

Intervention Type: OTHER

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

Group C

Caudal block group will receive 1 ml/kg of 0.25% bupivacaine.

Group Type: ACTIVE_COMPARATOR

Caudal Block Anesthesia

Intervention Type: OTHER

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.

Group EOI

External oblique intercostal block will recive 0.5 ml/kg 0.25 % bupivacaine bilaterally.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Zakarea Wfa

Assisted professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohamed Zakarea Wfa

Tanta, , Egypt

Countries

Egypt

Other Identifiers

36264PR1119/3/25

Identifier Type: -

Identifier Source: org_study_id