Clinical trial NCT06530147: Transversalis Fascia Plane Block vs Transversus Abdominis Plane Block In Pediatric Surgeries
Official title: Comparison Of The Effectiveness Of Transversalis Fascia Plane Block And Transversus Abdominis Plane Block For Postoperative Analgesia After Pediatric Lower Abdominal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Analgesia
Keywords: Regional anaesthesia
Transversus Abdominis Plane Block
Transversalis Fascia Plane Block
Pediatric Lower Abdominal Surgery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Pain scores
timeFrame: at the 6th postoperative hou
Secondary outcomes:
measure: Pain scores
timeFrame: During postoperative 24 hours
measure: Need for analgesic
timeFrame: During postoperative 24 hours
measure: Nause and vomiting
timeFrame: During postoperative 24 hours
measure: Parents satisfaction
timeFrame: During postoperative 24 hours
measure: Time elapsed until the first analgesic requirement
timeFrame: During postoperative 24 hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Hasibe Irban
Study officials:
affiliation: Kocaeli University
name: Can Aksu
role: STUDY_DIRECTOR
References: