Multifidus Plane Block Versus Caudal Block for Hypospadias

NCT ID: NCT06561269

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2025-12-01

Brief Summary

This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

Detailed Description

Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.

Conditions

Hypospadias; Caudal Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Multifidus plane block (MPB) group

Participants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3

Group Type: EXPERIMENTAL

Multifidus plane block

Intervention Type: PROCEDURE

Using the "in-plane" technique,The fascial plane between the multifidus muscle and the median sacral crests of S2 and S3, will be injected by bupivacaine.

Caudal block (CB) group

Participants will be injected by bupivacaine, between the two sacral cornua

Group Type: EXPERIMENTAL

caudal block

Intervention Type: PROCEDURE

The ultrasound transducer will first be placed transversely at the midline to obtain the transverse view of sacral hiatus. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus. The block needle is inserted using the "in-plane" technique.

Interventions

Multifidus plane block

Using the "in-plane" technique,The fascial plane between the multifidus muscle and the median sacral crests of S2 and S3, will be injected by bupivacaine.

Intervention Type: PROCEDURE

caudal block

The ultrasound transducer will first be placed transversely at the midline to obtain the transverse view of sacral hiatus. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus. The block needle is inserted using the "in-plane" technique.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ⦁ Children aged (1 -7) years old.

• All patients will be of ASA classification I, II physical status

Exclusion Criteria

• ⦁ Parents refusing to participate are excluded from the trial.

• Children who had spinal anomalies, altered mental status.
• A history of developmental delay.
• Blood diseases: Coagulopathy or anaemia.
• Infection at the site of injection.
• Drug allergy.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Tarek

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD73/2024

Identifier Type: -

Identifier Source: org_study_id