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

NCT ID: NCT06883370

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-30

Brief 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

Inguinal Hernia; Surgery; Paediatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All patients

All paediatric patients undergoing inguinal hernia repair

Group Type: EXPERIMENTAL

ultrasound-guided transversals fascia plane block with ropivacaine

Intervention Type: COMBINATION_PRODUCT

using 0.375% ropivacaine of 0.4mls/kg

Interventions

ultrasound-guided transversals fascia plane block with ropivacaine

using 0.375% ropivacaine of 0.4mls/kg

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr

Role: PRINCIPAL_INVESTIGATOR

The National University of Malaysia

Locations

The National University of Malaysia

Kuala Lumpur, , Malaysia

Countries

Malaysia

Other Identifiers

JEPUKM-JEP-2023-518

Identifier Type: -

Identifier Source: org_study_id