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NCT Number: NCT06725667

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

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.

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Key information

Conditions

Ultrasound Caudal Block Children Inguinal Herniorrhaphy Postoperative Analgesia Transversalis Fascia Plane Block

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

transversalis fascia plane block

Other

Patients will receive transversalis fascia plane block after the induction of general anesthesia.

Caudal block

Other

Patients will receive caudal block after the induction of general anesthesia.

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).

Secondary outcomes

  1. Total paracetamol consumption

    Time frame: 24 hours postoperatively

    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.

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    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).

  3. Degree of pain

    Time frame: 24 hours postoperatively

    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.

  4. Hear rate

    Time frame: Every 15 min till the end of surgery (Up to 2 hours)

    Hear rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.

  5. Mean arterial pressure

    Time frame: Every 15 min till the end of surgery (Up to 2 hours)

    Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.

  6. Degree of patient's parents satisfaction

    Time frame: 24 hours postoperatively

    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)

  7. Incidence of adverse events

    Time frame: 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 30, 2025

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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