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Multifidus Plane Block Versus Caudal Block for Hypospadias

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06561269
Enrollment
30
Registered
2024-08-20
Start date
2024-12-01
Completion date
2025-04-07
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caudal Block, Hypospadias

Keywords

Hypospadias, caudal block

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.

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
1 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
is to measure the first time to rescue analgesia postoperative (24 hours).24 hours postoperativeMeasure the first time to rescue analgesia post operative

Secondary

MeasureTime frameDescription
Heart ratestart to end of surgerymeasuring HR changes
Blood pressurestart to end of the surgery.measuring BP changes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026