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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Other: Transversalis Fascia Plane Block; Other: Transversus Abdominis Plane Block

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41000
    • Hasibe Irban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 1 and 7 years who will undergo abdominal surgery will be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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; One-side ultrasound (US)-guided Transversus abdominis plane (TAP) block with 0.25% bupivacaine will performe after placement laryngeal mask airway before surgery.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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.	at the 6th postoperative hou

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for analgesic	It should be recorded whether there is a need for analgesics.	During postoperative 24 hours
Nause and vomiting	The presence or absence of nausea and vomiting symptoms will be recorded.	During postoperative 24 hours
Time elapsed until the first analgesic requirement	What type of analgesic is needed. The time elapsed until the first analgesic requirement was recorded.	During postoperative 24 hours
Pain scores	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.	During postoperative 24 hours
Parents satisfaction	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.	During postoperative 24 hours

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Study Director: can aksu, Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Transversus Abdominis Plane Block; Regional anaesthesia; Transversalis Fascia Plane Block; Pediatric Lower Abdominal Surgery
• Other Study ID Numbers: KAEK/06.bl.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No