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Clinical Trials/NCT06725667
NCT06725667
Completed
N/A

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

Tanta University1 site in 1 country50 target enrollmentDecember 11, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ultrasound
Sponsor
Tanta University
Enrollment
50
Locations
1
Primary Endpoint
Time to the 1st rescue analgesia
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
December 11, 2024
End Date
December 6, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Total paracetamol consumption(24 hours postoperatively)
  • Intraoperative fentanyl consumption(Intraoperatively)
  • Degree of pain(24 hours postoperatively)
  • Hear rate(Every 15 min till the end of surgery (Up to 2 hours))
  • Mean arterial pressure(Every 15 min till the end of surgery (Up to 2 hours))
  • Degree of patient's parents satisfaction(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)

Study Sites (1)

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