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

NCT07235475 | Completed Phase 3

• 1 other identifier: MS-393-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total intraoperative fentanyl consumption

  from the start of general anesthesia until the extubation

• Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores

  24 hours postoperatively

• Total paracetamol dose in 24 hours

  24 hours postoperatively

• Parental satisfaction score

  24 hours postoperatively

Study Arms (2)

Fascia Transversalis Block

ACTIVE COMPARATOR

Patients will receive Fascia Transversalis Block

Procedure: Fascia Transversalis Block

caudal block

ACTIVE COMPARATOR

Patients will receive caudal block

Procedure: Caudal Block Anesthesia

Interventions

Caudal Block Anesthesia 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)

caudal block

Fascia Transversalis Block 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)

Fascia Transversalis Block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alaini hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anaesthesia

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 14, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-11

Locations

EG (1)