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CompletedNCT07235475Updated Apr 17, 2026

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

A Phase 3 interventional study of Caudal Block Anesthesia and Fascia Transversalis Block in Post Operative Pain, Acute, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Cairo University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
1 Year to 7 Years
Sex
All
01

Study 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

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Conditions studied

  • Post Operative Pain, Acute

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 50 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Fascia Transversalis Block

    Patients will receive Fascia Transversalis Block

    Procedure: Fascia Transversalis Block

  • Active comparator
    caudal block

    Patients will receive caudal block

    Procedure: Caudal Block Anesthesia

Interventions

  • ProcedureCaudal 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)

  • ProcedureFascia 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)

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What researchers measure

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)

    Time frame: 24 hours post-operatively

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

    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).

    Time frame: 24 hours postoperatively

  3. Total paracetamol dose in 24 hours

    Time frame: 24 hours postoperatively

  4. Parental satisfaction score

    Will be measured using a 5-point Likert scale: 1. = Extremely dissatisfied 2. = Unsatisfied 3. = Neutral 4. = Satisfied 5. = Extremely satisfied

    Time frame: 24 hours postoperatively

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Study locations

1 site
  • Kasr Alaini hospital
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07235475
Lead sponsor
Cairo University
Responsible party
AbdElKhalik Mahmoud Shaban (Lecturer of anaesthesia, Cairo University) — Principal investigator
First posted
Nov 19, 2025
Start date
Nov 20, 2025
Primary completion
Apr 1, 2026
Completion
Apr 14, 2026
Last update
Apr 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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