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CompletedNCT06561269Updated Mar 3, 2026

Multifidus Plane Block Versus Caudal Block for Hypospadias

An interventional study of Multifidus plane block and caudal block in Hypospadias and Caudal Block, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to male participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Year to 7 Years
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Hypospadias
  • Caudal Block

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Keywords

  • Hypospadias
  • caudal block
03

In context

Hypospadias

131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

This study's enrollment of 30 is below the median of 68 across 102 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • ⦁ Children aged (1 -7) years old.

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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

  • Experimental
    Caudal block (CB) group

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

    Procedure: caudal block

Interventions

  • ProcedureMultifidus 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.

  • Procedurecaudal 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.

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What researchers measure

Primary outcomes

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

    Measure the first time to rescue analgesia post operative

    Time frame: 24 hours postoperative

Secondary outcomes

  1. Heart rate

    measuring HR changes

    Time frame: start to end of surgery

  2. Blood pressure

    measuring BP changes

    Time frame: start to end of the surgery.

07

Study locations

1 site
  • Ain Shams University
    Cairo, 11772, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06561269
Lead sponsor
Ain Shams University
Responsible party
Radwa Tarek (Dr., Ain Shams University) — Principal investigator
First posted
Aug 20, 2024
Start date
Dec 1, 2024
Primary completion
Mar 5, 2025
Completion
Apr 7, 2025
Last update
Mar 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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