The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedNovember 16, 2022
November 1, 2022
3 months
February 14, 2020
November 15, 2022
Conditions
Outcome Measures
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)
Postoperative first 24 hours
Secondary Outcomes (1)
Additional Analgesic
Postoperative first 24 hours
Study Arms (2)
Group C
NO INTERVENTIONGroup TFP
ACTIVE COMPARATORTransversalis fascia plane block, before the surgical procedure.
Interventions
Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair
You may not qualify if:
- American Society of Anesthesiologist's physiologic state III-IV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University
Erzurum, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 30658324BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 17, 2020
Study Start
September 29, 2021
Primary Completion
December 30, 2021
Study Completion
January 30, 2022
Last Updated
November 16, 2022
Record last verified: 2022-11