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The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair

Exclusion Criteria:

  • American Society of Anesthesiologist's physiologic state III-IV

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group C

Group TFP

Arm Description

Transversalis fascia plane block, before the surgical procedure.

Outcomes

Primary Outcome Measures

Pain Score
Pain will be evaluated with a FLACC (Face, Legs, Activity, Cry, Consolability) score of 0-10 (0= no pain and 10= worst pain)

Secondary Outcome Measures

Additional Analgesic
Additional Analgesic consumption during postoperative 24 hours

Full Information

First Posted
February 14, 2020
Last Updated
November 15, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04272320
Brief Title
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
Official Title
The Efficacy of Transversalis Fascia Plane Block on Postoperative Pain in Pediatric Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In patients undergoing lower abdominal surgery, postoperative pain management is frequently provided with systemic opioids use or neuraxial methods. Ultrasound-guided TFP block is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management. TFP block provides anesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves. In this study, we aimed to evaluate the effects of ultrasound-guided TFP Block on postoperative pain scores in pediatric lower abdominal surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
No Intervention
Arm Title
Group TFP
Arm Type
Active Comparator
Arm Description
Transversalis fascia plane block, before the surgical procedure.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine
Primary Outcome Measure Information:
Title
Pain Score
Description
Pain will be evaluated with a FLACC (Face, Legs, Activity, Cry, Consolability) score of 0-10 (0= no pain and 10= worst pain)
Time Frame
Postoperative first 24 hours
Secondary Outcome Measure Information:
Title
Additional Analgesic
Description
Additional Analgesic consumption during postoperative 24 hours
Time Frame
Postoperative first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair Exclusion Criteria: American Society of Anesthesiologist's physiologic state III-IV
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30658324
Citation
Ahiskalioglu A, Aydin ME, Doymus O, Yayik AM, Celik EC. Ultrasound guided transversalis fascia plane block for lower abdominal surgery: First pediatric report. J Clin Anesth. 2019 Aug;55:130-131. doi: 10.1016/j.jclinane.2018.12.046. Epub 2019 Jan 15. No abstract available.
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The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair

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