Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy

Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial

The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.

Study Overview

• Status: Completed
• Conditions: Children; Caudal Block; Ultrasound; Postoperative Analgesia; Inguinal Herniorrhaphy; Transversalis Fascia Plane Block
• Intervention / Treatment: Other: Transversalis fascia plane block; Other: Caudal block

Detailed Description

Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.

Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.

transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age from 1 to 7 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for inguinal herniorrhaphy under general anesthesia (GA).

Exclusion Criteria:

• Repeated surgeries.
• Known allergic reactions to any of the study's drugs.
• Infection at the site of block needle entry.
• Bleeding diathesis.
• Neurological disorders.

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
Experimental: Transversalis fascia plane block group; Patients will receive transversalis fascia plane block after the induction of general anesthesia.	Other: Transversalis fascia plane block; Patients will receive transversalis fascia plane block after the induction of general anesthesia.
Active Comparator: Caudal block group; Patients will receive caudal block after the induction of general anesthesia.	Other: Caudal block; Patients will receive caudal block after the induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).	Intraoperatively
Total paracetamol consumption	Each of the five items of the Face, legs, activity, cry, and consolability (FLACC) scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity. If the FLACC scale exceeds three, IV paracetamol (15 mg/kg) will be given.	24 hours postoperatively
Degree of pain	Degree of pain will be assessed using the Face, legs, activity, cry, and consolability (FLACC) scale. Each of the five items of the FLACC scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity.	24 hours postoperatively
Hear rate	Hear rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.	Every 15 min till the end of surgery (Up to 2 hours)
Mean arterial pressure	Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.	Every 15 min till the end of surgery (Up to 2 hours)
Degree of patient's parents satisfaction	Degree of patient's parents satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to block such as hematoma, neurological injury, deep visceral injury, or local anesthetic toxicity will be recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Actual): December 6, 2025
• Study Completion (Actual): December 6, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Neurobehavioral Manifestations; Hernia; Hernia, Abdominal; Perceptual Disorders; Hernia, Inguinal; Agnosia
• Other Study ID Numbers: 36264PR935/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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