Multifidus Plane Block Versus Caudal Block for Hypospadias

Not Applicable

Not yet recruiting

• Conditions: Hypospadias; Caudal Block
• Interventions: Procedure: caudal block; Procedure: Multifidus plane block

• Registration Number: NCT06561269
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2024-06-02
• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block (CB) group	caudal block	Participants will be injected by bupivacaine, between the two sacral cornua
Multifidus plane block (MPB) group	Multifidus plane block	Participants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3

Primary Outcome Measures

Name	Time	Method
is to measure the first time to rescue analgesia postoperative (24 hours).	24 hours postoperative	Measure the first time to rescue analgesia post operative

Secondary Outcome Measures

Name	Time	Method
Heart rate	start to end of surgery	measuring HR changes
Blood pressure	start to end of the surgery.	measuring BP changes