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Completed

NCT Number: NCT06883370

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Paediatric Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The National University of Malaysia

Kuala Lumpur, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All ASA I or II patients undergoing inguinal hernia repair

Exclusion criteria

Parent's refusal, allergic to study drug

Treatment and study plan

ultrasound-guided transversals fascia plane block with ropivacaine

Combination Product

using 0.375% ropivacaine of 0.4mls/kg

Primary outcomes

  1. Effectiveness of ultrasound-guided transversals fascia plane block in paediatric

    Time frame: immediate post operative

    Pain score

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2025
Registry last updated
Mar 20, 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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