Multifidus Plane Block Versus Caudal Block for Hypospadias

NCT06561269 | Completed DMC

• 1 other identifier: MD73/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hypospadias; Caudal Block

Keywords

Hypospadias; caudal block

Outcome Measures

Primary Outcomes (1)

• is to measure the first time to rescue analgesia postoperative (24 hours).

  Measure the first time to rescue analgesia post operative

  24 hours postoperative

Secondary Outcomes (2)

• Heart rate

  start to end of surgery

• Blood pressure

  start to end of the surgery.

Study Arms (2)

Multifidus plane block (MPB) group

EXPERIMENTAL

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

Caudal block (CB) group

EXPERIMENTAL

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

Procedure: caudal block

Interventions

Multifidus plane block 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.

Multifidus plane block (MPB) group

caudal block 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.

Caudal block (CB) group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Gender Eligibility Details: Children aged (1 -7) years old.All patients will be of ASA classification I, II physical status
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ⦁ Children aged (1 -7) years old.
• All patients will be of ASA classification I, II physical status

You may not qualify if:

• ⦁ 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11772, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: August 20, 2024
• Study Start: December 1, 2024
• Primary Completion: March 5, 2025
• Study Completion: April 7, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)