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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04272320
Other study ID # Pediatrik TFP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 29, 2021
Est. completion date January 30, 2022

Study information

Verified date November 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 8 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologist's physiologic state I-II patients undergoing inguinal hernia repair Exclusion Criteria: - American Society of Anesthesiologist's physiologic state III-IV

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Hydrochloride
Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine

Locations

Country Name City State
Turkey Ataturk University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Additional Analgesic Additional Analgesic consumption during postoperative 24 hours Postoperative first 24 hours
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