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

Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block in Pediatrics Undergoing Inguinal Hernia Surgeries: Randomized Double-blinded Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Post Operative Pain, Acute
• Intervention / Treatment: Procedure: Fascia Transversalis Block; Procedure: Caudal Block Anesthesia

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fascia Transversalis Block; Patients will receive Fascia Transversalis Block	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)
Active Comparator: caudal block; Patients will receive caudal block	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first request for rescue analgesia	the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol)	24 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative fentanyl consumption		from the start of general anesthesia until the extubation
Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores	Each of the five behaviors will be scored on a scale of 0 to 2. The scores are then added together to get a total score, which can range from 0 (no pain) to 10 (severe pain).	24 hours postoperatively
Total paracetamol dose in 24 hours		24 hours postoperatively
Parental satisfaction score	Will be measured using a 5-point Likert scale: = Extremely dissatisfied; = Unsatisfied; = Neutral; = Satisfied; = Extremely satisfied	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: MS-393-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No