NCT06883370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 12, 2025

Last Update Submit

March 18, 2025

Conditions

Inguinal HerniaSurgeryPaediatric

Keywords

Ultrasoundtransversalis fasciaropivacaineinguinal herniapaediatric patients

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of ultrasound-guided transversals fascia plane block in paediatric

    Pain score

    immediate post operative

Study Arms (1)

All patients

EXPERIMENTAL

All paediatric patients undergoing inguinal hernia repair

Combination Product: ultrasound-guided transversals fascia plane block with ropivacaine

Interventions

ultrasound-guided transversals fascia plane block with ropivacaineCOMBINATION_PRODUCT

using 0.375% ropivacaine of 0.4mls/kg

All patients

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National University of Malaysia

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dr

    The National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 19, 2025

Study Start

December 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

MY(1)