Comparison of Analgesic Efficacy of Fascia Transversalis Plan Block and Caudal Epidural Block in Pediatric Patients Undergoing Orchiopexy

NCT07006844 | Not Yet Recruiting

• 1 other identifier: E-48670771-514.99-273708811...
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orchiopexy

Outcome Measures

Primary Outcomes (1)

• FLACC (The Faces, Legs, Activity, Cry and Consolability) pain scoring

  The Face, Legs, Activity, Crying, and Consolability (FLACC) scale is an observational pain scale. It is widely used in the pediatric population to assess pain in infants and children who cannot verbally express their pain. \[1\] Instead, the FLACC scale was developed to help patients understand their pain experience by observing facial expressions and behavioral patterns to enable the provision of effective pain intervention.

  Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours

Secondary Outcomes (1)

• Postoperative analgesic needs

  Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours

Study Arms (2)

fascia transversalis plan block group

In fascia transversalis plan block, it is aimed to block the ilioinguinal and iliohypogastric nerves by injecting local anesthetic into the fascia transversalis plane under ultrasound guidance. It is a preferred method for analgesia of inguinal and lower abdominal surgeries

Caudal epidural block group

Caudal epidural block is a regional anesthesia technique performed by administering local anesthetic or analgesic drugs into the epidural space through the sacral hiatus. It is frequently used in urogenital, rectal, inguinal and lower extremity surgeries.

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Related Publications (2)

• 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.

  PMID: 28616651 BACKGROUND

• 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.

  PMID: 31907294 RESULT

Central Study Contacts

ece ö özcan

CONTACT

+90 5305618506; eceozcan_1994@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 7, 2025
• Primary Completion: December 21, 2025
• Study Completion: January 7, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05