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Clinical Trials/NCT06530147
NCT06530147
Completed
Not Applicable

Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries

Kocaeli University1 site in 1 country84 target enrollmentJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Analgesia
Sponsor
Kocaeli University
Enrollment
84
Locations
1
Primary Endpoint
Pain scores
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, the investigators compared ultrasound-guided transversalis fascia plane (TFP) block and transversus abdominis plane (TAP) block on postoperative analgesic effect in pediatric abdominal surgeries

Detailed Description

After being informed about the study and potential risks, written consent was obtained from all patients. In order to effectively manage postoperative analgesia in patients planned for lower abdominal surgery (inguinal hernia and undescended testicles), patients will begin to be observed after routine anesthesia and block techniques applied to the patients. After these procedures, the block is applied to the patient using the appropriate method, under aseptic conditions and under ultrasound guidance. Intraoperative hemodynamic changes of the patients, intraoperative opioid consumption and bispectral index monitoring values of the patients will be kept throughout the peroperative period. Postoperative follow-ups will be made at 0nd, 1st, 2nd, 4th, 6th, 12th, and 24th hours to evaluate the initial analgesic consumption, need for analgesics types, pain levels, and parental satisfaction. In this way, it is aimed to compare the Transversalis Fascia Plan Block and Transversus Abdominis Plan Block as an effective analgesic application in lower abdominal surgery in children and to show the analgesic method that can be used effectively in postoperative pain management.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
August 6, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hasibe Irban

Principal Investigator

Kocaeli University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologist Classification (ASA) I-II patients
  • 1-7 aged patients
  • patients who scheuled elective lower abdominal surgery (inguinal hernia and undescended testis)

Exclusion Criteria

  • Use of anticoagulants
  • Allergy of medications to be used
  • Presence of infection the area where the block will be applied
  • American Society of Anesthesiologist Classification (ASA) III-IV patients
  • The study will not include any vulnerable population, such as those in restraints, those in intensive care and those who are unconscious, and those who cannot give personal consent or impressionable subjects.
  • Patients who do not agree to participate in the research, parents/legal guardians
  • Patients who were operated on with a different incision than planned for any reason.

Outcomes

Primary Outcomes

Pain scores

Time Frame: at the 6th postoperative hou

Our primary aim to compare the effect of both blocks groups on the FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at the 6th postoperative hour. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.

Secondary Outcomes

  • Need for analgesic(During postoperative 24 hours)
  • Nause and vomiting(During postoperative 24 hours)
  • Parents satisfaction(During postoperative 24 hours)
  • Pain scores(During postoperative 24 hours)
  • Time elapsed until the first analgesic requirement(During postoperative 24 hours)

Study Sites (1)

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