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NCT Number: NCT07235475

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

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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Key information

Conditions

Post Operative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

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)

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)

Primary outcomes

  1. Time to the first request for rescue analgesia

    Time frame: 24 hours post-operatively

    the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol)

Secondary outcomes

  1. Total intraoperative fentanyl consumption

    Time frame: from the start of general anesthesia until the extubation

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

    Time frame: 24 hours postoperatively

    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).

  3. Total paracetamol dose in 24 hours

    Time frame: 24 hours postoperatively

  4. Parental satisfaction score

    Time frame: 24 hours postoperatively

    Will be measured using a 5-point Likert scale:

    • = Extremely dissatisfied
    • = Unsatisfied
    • = Neutral
    • = Satisfied
    • = Extremely satisfied

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Apr 17, 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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