Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy: A Prospective Observational Study

NCT07762339 | Recruiting

• 1 other identifier: E-48670771-514.99-3229225
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the analgesic efficacy of ultrasound-guided erector spinae plane block and caudal block for postoperative pain management in pediatric patients undergoing orchiopexy. Postoperative pain scores, time to first rescue analgesic requirement, total analgesic consumption, and block-related adverse effects will be evaluated during the first 24 hours after surgery. The study will assess whether erector spinae plane block provides effective postoperative analgesia comparable to or superior to caudal block in pediatric orchiopexy.

Conditions

Caudal Epidural Anesthesia; Sacral Erector Spinae Plane Block; Orchiopexy; FLACC Scale

Keywords

FLACC SCALE; caudal epidural anesthesia; sacral erector spinae plane block; orchiopexy

Outcome Measures

Primary Outcomes (1)

• Time To First Analgesic Requirement After Surgery

  The time elapsed from the end of surgery to the administration of the first rescue analgesic

  First 24 hours postoperatively

Secondary Outcomes (1)

• FLACC Pain Scores at Specified Time Intervals

  first 24 hours postoperatively

Study Arms (2)

Children aged 1-7 years undergoing orchiopexy who received a sacral erector spinae plane block

Children aged 1-7 years undergoing orchiopexy who received a sacral erector spinae plane block

Children aged 1-7 years undergoing orchiopexy who received a caudal block

Children aged 1-7 years undergoing orchiopexy who received a caudal block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 to 7 years with ASA physical status I-II undergoing orchiopexy surgery.

You may qualify if:

• Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.

You may not qualify if:

• ASA physical status ≥ III
• History of prematurity (gestational age \< 37 weeks) Known coagulation disorders or bleeding tendency
• Infection, inflammation, or skin lesion at the injection site
• Known neurological or neuromuscular diseases
• Presence of significant cardiac or pulmonary disease (e.g., congenital heart disease, active asthma)
• Hepatic or renal dysfunction
• Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine, lidocaine)
• Developmental delay or cognitive impairment that prevents accurate pain assessment
• Use of additional regional analgesia techniques (e.g., caudal block) during surgery
• Lack of parental consent for participation in the study

Sponsors & Collaborators

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

Study Sites (1)

Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, şişli, 34384, Turkey (Türkiye)

RECRUITING

Study Officials

• kübra demir

  Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra DEMİR

CONTACT

905355573969; kubrademir01@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): January 8, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

TU (1)