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CompletedNCT04272320Updated Nov 16, 2022

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

An interventional study of Bupivacaine Hydrochloride in Inguinal Hernia, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2022-11-16.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 8 Years
Sex
All
01

Study 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.

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Conditions studied

  • Inguinal Hernia
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In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Group C
  • Active comparator
    Group TFP

    Transversalis fascia plane block, before the surgical procedure.

    Drug: Bupivacaine Hydrochloride

Interventions

  • DrugBupivacaine Hydrochloride

    Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Postoperative first 24 hours

Secondary outcomes

  1. Additional Analgesic

    Additional Analgesic consumption during postoperative 24 hours

    Time frame: Postoperative first 24 hours

07

Study locations

1 site
  • Ataturk University
    Erzurum, Turkey
08

References and documents

Publications

  • 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. PubMed 30658324 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04272320
Lead sponsor
Ataturk University
Responsible party
Elif Oral Ahiskalioglu (Associate Professor, Ataturk University) — Principal investigator
First posted
Feb 17, 2020
Start date
Sep 29, 2021
Primary completion
Dec 30, 2021
Completion
Jan 30, 2022
Last update
Nov 16, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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