Multifidus Plane Block Versus Caudal Block for Hypospadias

February 28, 2026 updated by: Radwa Tarek, Ain Shams University

Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

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
      • Cairo, Egypt, 11772
        • Ain shams university

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

No

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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.
Experimental: Caudal block (CB) group
Participants will be injected by bupivacaine, between the two sacral cornua
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
is to measure the first time to rescue analgesia postoperative (24 hours).
Time Frame: 24 hours postoperative
Measure the first time to rescue analgesia post operative
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: start to end of surgery
measuring HR changes
start to end of surgery
Blood pressure
Time Frame: start to end of the surgery.
measuring BP changes
start to end of the surgery.

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

December 1, 2024

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

April 7, 2025

Study Registration Dates

First Submitted

June 2, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD73/2024

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.

Clinical Trials on Hypospadias

Clinical Trials on Multifidus plane block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe