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NCT Number: NCT07006844

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

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.

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Key information

Conditions

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Postoperative analgesic needs

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

    Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours analgesic consumption will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

+90 5305618506

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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