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Completed

NCT Number: NCT06561269

Multifidus Plane Block Versus Caudal Block for Hypospadias

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

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Key information

Conditions

Hypospadias Caudal Block Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

1 year–7 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11772, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Heart rate

    Time frame: start to end of surgery

    measuring HR changes

  2. Blood pressure

    Time frame: start to end of the surgery.

    measuring BP changes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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