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Not yet recruiting NCT07006844

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

Observational Orchiopexy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Orchiopexy. Basic parameters: 1 year — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • FLACC (The Faces, Legs, Activity, Cry and Consolability) pain scoring [Time frame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours]
Secondary outcome measures (1)
  • Postoperative analgesic needs [Time frame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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

Identifiers

NCT: NCT07006844 · E-48670771-514.99-273708811...

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗