Transversalis Fascia Plane Block in Pediatric Patients

April 26, 2024 updated by: Çağdaş Baytar, Zonguldak Bulent Ecevit University

Effects of Transversalis Fascia Plane Block in Pediatric Patients Undergoing Inguinal Hernia and Orchiopexy Surgeries

to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University medicine faculty

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:

  • 1-9 years old
  • ASA I-II risk group
  • Patients whose consent was obtained from their parents with an informed consent form
  • Patients who will undergo Inguinal Hernia or Undescended Testi

Exclusion Criteria:

  • ASA >2
  • History of allergy to local anesthetics
  • Known coagulation disorders
  • Infection near the entry site
  • Body mass index >30
  • Those whose parents refused to participate in the study
  • Those contraindicated for regional anesthesia
  • Those with neurological or neuromuscular disease
  • Patients with psychiatric problems
  • Patients with a history of opioid use
  • Chronic analgesic use
  • Operation duration exceeding 2 hours

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group Control
Active Comparator: Group FTB
Procedure: Transversalis Fascia Plane Block
application of local anesthetic between the transversus abdominis muscle and the transversalis fascia surrounding it from the inside, at the level of the posterior axillary line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scores
Time Frame: up to 24 hour after surgery
Patients will be evaluated at regular intervals after surgery and their pain will be measured using a FLACC scores.
up to 24 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parental satisfaction
Time Frame: during the procedure
asking parents about their satisfaction
during the procedure

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit University

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)

April 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/06-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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