Caudal Epidural AnesthesiaNCT07762339
Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy: A Prospective Observational Study
An observational study of Caudal Epidural Anesthesia and Sacral Erector Spinae Plane Block, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caudal Epidural Anesthesia, Sacral Erector Spinae Plane Block, Orchiopexy
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2026to 8 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Children aged 1 to 7 years with ASA physical status I-II undergoing orchiopexy surgery.
Who may be able to join
- Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Who cannot join
- 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
Show all 11Show fewer
- 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
- Block failure or intraoperative complications requiring exclusion from protocol analysis
- Lack of parental consent for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, şişli, 34384
kübra demir, 905355573969, kubrademir01@yahoo.com.tr
About this study
Official title: Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy
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.
- Keywords
- FLACC SCALE, caudal epidural anesthesia, sacral erector spinae plane block, orchiopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To First Analgesic Requirement After Surgery
The time elapsed from the end of surgery to the administration of the first rescue analgesic
Measured: 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
Measured: first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start8 Jun 2026
- Primary completion8 Jan 2027 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal Epidural AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Demir, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- kübra demir, Principal investigator, Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762339
- Sponsor's protocol ID
- E-48670771-514.99-3229225
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block and Caudal Block for Postoperative Analgesia in Pediatric Patients Undergoing Orchiopexy
- ClinicalTrials.gov ID
- NCT07762339
- Acronym / sponsor ID
- E-48670771-514.99-3229225
- Keywords
- FLACC SCALE, caudal epidural anesthesia, sacral erector spinae plane block, orchiopexy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1 to 7 years with ASA physical status I-II undergoing orchiopexy surgery.
Key inclusion criteria (1 listed)
- Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time To First Analgesic Requirement After Surgery
Time frame: First 24 hours postoperatively
The time elapsed from the end of surgery to the administration of the first rescue analgesic
1 secondary outcome
FLACC Pain Scores at Specified Time Intervals
Time frame: first 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
kübra demir principal investigator
Prof. Dr Cemil Taşcıoğlu Şehir Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caudal Epidural Anesthesia and Sacral Erector Spinae Plane Block, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kübra DEMİR (905355573969, kubrademir01@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To First Analgesic Requirement After Surgery (time frame: First 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.