ClinicalTrials.gg
RecruitingNCT07762339Updated Aug 13, 2026

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

An observational study in Caudal Epidural Anesthesia, Sacral Erector Spinae Plane Block and Orchiopexy, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 1 Year to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
84
Ages
1 Year to 7 Years
Sex
Male
01

Study 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.

02

Conditions studied

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

Keywords

  • FLACC SCALE
  • caudal epidural anesthesia
  • sacral erector spinae plane block
  • orchiopexy
03

In context

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ≥ 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 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
  • Block failure or intraoperative complications requiring exclusion from protocol analysis
  • Lack of parental consent for participation in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
84 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

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

    Time frame: First 24 hours postoperatively

Secondary outcomes

  1. FLACC Pain Scores at Specified Time Intervals

    Pain assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (score range: 0-10; higher scores indicate worse pain) at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours postoperatively

    Time frame: first 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07762339
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible party
Kübra Demir (resident doctor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization) — Principal investigator
First posted
Aug 13, 2026
Start date
Jun 8, 2026
Primary completion
Jan 8, 2027 (estimated)
Completion
Jan 8, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Kübra DEMİR
Contact
kubrademir01@yahoo.com.tr
905355573969
kübra demir
principal investigator · Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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