Clinical Trials Directory

Trials / Completed

CompletedNCT06883370

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

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.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
32 (actual)
Sponsor
National University of Malaysia · Academic / Other
Sex
All
Age
6 Months – 12 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTultrasound-guided transversals fascia plane block with ropivacaineusing 0.375% ropivacaine of 0.4mls/kg

Timeline

Start date
2023-12-01
Primary completion
2024-11-30
Completion
2024-11-30
First posted
2025-03-19
Last updated
2025-03-20

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT06883370. Inclusion in this directory is not an endorsement.