Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries

Completed

• Conditions: Postoperative Analgesia
• Interventions: Other: Transversalis Fascia Plane Block; Other: Transversus Abdominis Plane Block

• Registration Number: NCT06530147
• Lead Sponsor: Kocaeli University

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-26
• Primary Completion: 2024-07-29
• Study First Posted: 2024-07-31
• Status Verified: 2024-08
• Study Completion: 2024-08-06
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transversalis Fascia Plane Block	Transversalis Fascia Plane Block	One-side ultrasound (US)-guided Transversalis fascia plane (TFP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.
Transversus Abdominis Plane Block	Transversus Abdominis Plane Block	One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.

Primary Outcome Measures

Name	Time	Method
Pain scores	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 Outcome Measures

Name	Time	Method
Need for analgesic	During postoperative 24 hours	It should be recorded whether there is a need for analgesics.
Nause and vomiting	During postoperative 24 hours	The presence or absence of nausea and vomiting symptoms will be recorded.
Parents satisfaction	During postoperative 24 hours	Parental satisfaction was assessed on a scale ranging from 1 to 5 points parents satisfaction with the applied analgesia methods was evaluated on a scale from 1, indicating the lowest satisfaction, to 5, indicating the highest satisfaction.
Pain scores	During postoperative 24 hours	Secondary objectives will include comparison of patient FLACC (Face, Legs, Activity, Cry, Consolability) pain scores in 24-hour observations of patients. FLACC pain scale, zero is designated as the lowest pain level, and ten as the highest pain level.
Time elapsed until the first analgesic requirement	During postoperative 24 hours	What type of analgesic is needed. The time elapsed until the first analgesic requirement was recorded.

Trial Locations

Locations (1)

Hasibe Irban; 🇹🇷 Kocaeli, Turkey