Analgesia Evaluation of an Ultrasound-guided Technique for Inguinal Hernia Surgery in Children in Children

March 18, 2025 updated by: National University of Malaysia

Analgesic Evaluation of Ultrasound Guided Transversalis Fascia Plane (Tfp) Block With 0.4 ml/kg of Ropivacaine 0.375 % in Paediatric Laparoscopic Inguinal Hernia Repair.

The basis for the transversalis fascia plane (TFP) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. The fascia of the transversus abdominis muscle, also called the thoracolumbar fascia, is formed when the transversus abdominis and internal oblique muscles taper off posteriorly into a common aponeurosis and abuts the lateral border of quadratus lumborum muscle. The transversalis fascia is a thin aponeurotic membrane which lies between the transversus abdominis muscle and the extraperitoneal fascia, and is part of the general layer of fascia lining the abdominal cavity. Thus the TFP block is said to be suitable for lower abdominal surgery.

This study was designed obtain the analgesic efficacy of ropivacaine 0.375% for ultrasound-guided (USG) TFP block for paediatric patients undergoing laparoscopic inguinal hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: Thirty-two ASA 1 or 2 patients, aged 6 months to 12 years old undergoing laparoscopic inguinal hernia repair were recruited into this study. They were all given 0.4ml/kg of ropivacaine 0.375% after induction of anaesthesia. Intra operative heart rate (HR), mean arterial pressure (MAP), cumulative fentanyl consumption as well as post operative FLACC score, post operative nausea and vomiting incidence, time to first oral intake, parental satisfaction and complications were recorded.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • The National University of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: All ASA I or II patients undergoing inguinal hernia repair

Exclusion Criteria: Parent's refusal, allergic to study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
All paediatric patients undergoing inguinal hernia repair
Combination product: ultrasound-guided transversals fascia plane block with ropivacaine
using 0.375% ropivacaine of 0.4mls/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of ultrasound-guided transversals fascia plane block in paediatric
Time Frame: immediate post operative
Pain score
immediate post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Dr, The National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEPUKM-JEP-2023-518

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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