Clinical trial NCT07006844: Comparison of Analgesic Efficacy of Fascia Transversalis Plan Block and Caudal Epidural Block in Pediatric Patients Undergoing Orchiopexy
Official title: Comparison of Analgesic Efficacy of Fascia Transversalis Plan Block and Caudal Epidural Block in Pediatric Patients Undergoing Orchiopexy. Our Study, it Was Planned to Compare the Postoperative Analgesic Efficacy of Routinely Applied Fascia Transversalis Plan Block and Caudal Epidural Block for Analgesia After General Anesthesia in Pediatric Patients Undergoing Orchiopexy (Unilateral) According to the Surgery and Suitability of the Patient and the Competence of the Anesthesiologist
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orchiopexy
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA I-II, patients who will undergo unilateral orchiopexy under general anesthesia, patients between the ages of 1-7 years

Brief summary: Orchiopexy is a surgery with a high frequency in the pediatric population. The use of regional anesthesia techniques has become widespread and its importance has increased in order to provide more effective and prolonged perioperative analgesia, as well as to prevent the side effects of opioids such as respiratory depression and to reduce systemic analgesic consumption. In this study, it was planned to compare the postoperative analgesic efficacy of routinely applied fascia transversalis plan block and caudal epidural block for analgesia after general anesthesia in pediatric patients undergoing orchiopexy (unilateral) according to the surgery and suitability of the patient and the competence of the anesthesiologist.

ASA I-II, patients who will undergo unilateral orchiopexy under general anesthesia, patients between the ages of 1-7 years, who have no contraindications for block application, and whose participation in the study is accepted by their legal guardian will be included in the study. After induction of general anesthesia and ensuring airway safety with a laryngeal mask, one of the regional anesthesia methods (fascia transversalis plan block or caudal epidural block) deemed appropriate for the patient is applied by the specialist of the room before the surgical incision. Postoperative analgesic needs of the patients and FLACC score will be evaluated at 30 minutes, 1, 2, 4, 6, 12 and 24 hours postoperatively.


Eligibility criteria: Inclusion Criteria:

ASA I-II, patients who will undergo unilateral orchiopexy under general anesthesia patients between the ages of 1-7 years, who have no contraindications for block application, and whose participation in the study is accepted by their legal guardian will be included in the study.

Exclusion Criteria:

Lack of consent by the patient's legal guardian, contraindications for block (bleeding diathesis, regional infection, neuromuscular disease), patients over 7 years of age

Primary outcomes:
measure: FLACC (The Faces, Legs, Activity, Cry and Consolability) pain scoring
timeFrame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours
Secondary outcomes:
measure: Postoperative analgesic needs
timeFrame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Okur O, Tekgul ZT, Erkan N. Comparison of efficacy of transversus abdominis plane block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing inguinal herniorrhaphy with spinal anesthesia: a prospective randomized controlled open-label study. J Anesth. 2017 Oct;31(5):678-685. doi: 10.1007/s00540-017-2378-3. Epub 2017 Jun 14.
citation: Oksuz G, Arslan M, Urfalioglu A, Guler AG, Teksen S, Bilal B, Oksuz H. Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial. Reg Anesth Pain Med. 2020 Mar;45(3):187-191. doi: 10.1136/rapm-2019-101027. Epub 2020 Jan 5.