OrchiopexyNCT07006844
Comparison of Analgesic Efficacy of Fascia Transversalis Plan Block and Caudal Epidural Block in Pediatric Patients Undergoing Orchiopexy
An observational study of Orchiopexy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men only
- Conditions the study is for
- Orchiopexy
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 21 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child
Study population: ASA I-II, patients who will undergo unilateral orchiopexy under general anesthesia, patients between the ages of 1-7 years
Who may be able to join
- ASA physical status I-II
- Patients undergoing unilateral orchiopexy under general anesthesia
- Age between 1 and 7 years
- No contraindications to block application
- Written informed consent provided by the patient's legal guardian
Who cannot join
- Lack of consent from the patient's legal guardian
- Contraindications to block application (bleeding diathesis, infection at the block site, or neuromuscular disease)
- Age over 7 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul
About this study
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
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.
- Conditions
- 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 |
|---|---|---|
| fascia transversalis plan block group | In fascia transversalis plan block, it is aimed to block the ilioinguinal and iliohypogastric nerves by injecting local anesthetic into the fascia transversalis plane under ultrasound guidance. It is a preferred method for analgesia of inguinal and lower abdominal surgeries | |
| Caudal epidural block group | Caudal epidural block is a regional anesthesia technique performed by administering local anesthetic or analgesic drugs into the epidural space through the sacral hiatus. It is frequently used in urogenital, rectal, inguinal and lower extremity surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC (The Faces, Legs, Activity, Cry and Consolability) pain scoring
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.
Measured: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours
Secondary outcomes (1)
Postoperative analgesic needs
Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours analgesic consumption will be recorded
Measured: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start21 Apr 2025
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OrchiopexyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- 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, Ece Ozcan, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006844
- Sponsor's protocol ID
- E-48670771-514.99-273708811...
- Status last verified
- Oct 2026
- First submitted
- 28 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28616651Oksuz 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.
PubMed 31907294
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07006844
- Acronym / sponsor ID
- E-48670771-514.99-273708811...
- Conditions
- Orchiopexy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 5 Jun 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascia transversalis plan block group | – | –In fascia transversalis plan block, it is aimed to block the ilioinguinal and iliohypogastric nerves by injecting local anesthetic into the fascia transversalis plane under ultrasound guidance. It is a preferred method for analgesia of inguinal and lower abdominal surgeries |
| Caudal epidural block group | – | –Caudal epidural block is a regional anesthesia technique performed by administering local anesthetic or analgesic drugs into the epidural space through the sacral hiatus. It is frequently used in urogenital, rectal, inguinal and lower extremity surgeries. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ASA I-II, patients who will undergo unilateral orchiopexy under general anesthesia, patients between the ages of 1-7 years
Key inclusion criteria (5 listed)
- ASA physical status I-II
- Patients undergoing unilateral orchiopexy under general anesthesia
- Age between 1 and 7 years
- No contraindications to block application
- Written informed consent provided by the patient's legal guardian
Key exclusion criteria (3 listed)
- Lack of consent from the patient's legal guardian
- Contraindications to block application (bleeding diathesis, infection at the block site, or neuromuscular disease)
- Age over 7 years
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
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.
1 secondary outcome
Postoperative analgesic needs
Time frame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 28616651Okur 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.
- Background: PubMed 31907294Oksuz 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Orchiopexy, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC (The Faces, Legs, Activity, Cry and Consolability) pain scoring (time frame: Postoperative 30 minutes 1, 2, 4, 6, 12 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07006844, which also lists 2 linked publications.
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 3 Nov 2026.