Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2026-06-30

Brief Summary

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Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing unilateral inguinal hernia repair. This study aims to address this gap by providing the first head-to-head randomized comparison between both blocks in a standardized surgical setting

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Detailed Description

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Conditions

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Post Operative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fascia Transversalis Block

Patients will receive Fascia Transversalis Block

Group Type ACTIVE_COMPARATOR

Fascia Transversalis Block

Intervention Type PROCEDURE

Patients will receive Fascia Transversalis Block using 0.5 mL/kg of Bupivacaine 0.25% . The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)

caudal block

Patients will receive caudal block

Group Type ACTIVE_COMPARATOR

Caudal Block Anesthesia

Intervention Type PROCEDURE

Patients will receive a caudal block with 0.5 mL/kg of Bupivacaine 0.25% injected. The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)

Interventions

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Caudal Block Anesthesia

Patients will receive a caudal block with 0.5 mL/kg of Bupivacaine 0.25% injected. The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)

Intervention Type PROCEDURE

Fascia Transversalis Block

Patients will receive Fascia Transversalis Block using 0.5 mL/kg of Bupivacaine 0.25% . The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I or II, scheduled for elective unilateral inguinal hernia surgery under general anesthesia

Exclusion Criteria

* Parental refusal.
* Pre-existing infection at block site.
* Coagulopathy (defined as INR \>1.5, Platelets \<100,000).
* Known allergy to local anesthetics.
* History of complications from regional anesthesia.
* Emergency or bilateral hernia repair.
* Neurodevelopmental disorders (e.g., cerebral palsy, spina bifida).

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No