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

NCT06725667 | Completed

• 1 other identifier: 36264PR935/11/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Transversalis fascia plane block group

EXPERIMENTAL

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

Other: Transversalis fascia plane block

Caudal block group

ACTIVE COMPARATOR

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

Other: Caudal block

Interventions

Caudal block OTHER

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

Caudal block group

Transversalis fascia plane block OTHER

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

Transversalis fascia plane block group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 11, 2024
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)