Percutaneous Internal Ring SuturingNCT07147062
Comparison of the Postoperative Analgesic Effects of RSB and CEB in Pediatric Patients Scheduled for Percutaneous Internal Ring Suturing
A study testing Rectus Sheath Block and Caudal Epidural Block in people with Percutaneous Internal Ring Suturing and Pain Management, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia is one of the most common surgical pathologies in children, and the minimally invasive percutaneous internal ring suturing (PIRS) technique is widely preferred. By providing effective pain control, nerve blocks reduce postoperative opioid requirements, thereby minimising opioid-related adverse effects… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Percutaneous Internal Ring Suturing, Pain Management
- What is being tested?
- Rectus Sheath Block and Caudal Epidural Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 27 Feb 2026
- Phase
- Interventional
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 1 and 8 years
- ASA physical status I-II
- Patients who underwent PIRS surgery in the operating room and received either a rectus sheath block or a caudal epidural block
Who cannot join
- Patients younger than 1 year or older than 8 years
- ASA physical status ≥ III
- History of bleeding diathesis
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
Ankara Etlik City Hospital
Altındağ, Ankara, 06000
Elif Şule Özdemir Sezgi, M.D., 00905059209638, elifsule-91@hotmail.com
Aslı Dönmez, Professor, 00905322256473, aslidonmez@hotmail.com
About this study
Official title: Comparison of the Postoperative Analgesic Effects of Rectus Sheath Block and Caudal Epidural Block in Pediatric Patients Scheduled for Percutaneous Internal Ring Suturing
Inguinal hernia is one of the most common surgical pathologies in children, and the minimally invasive percutaneous internal ring suturing (PIRS) technique is widely preferred.
By providing effective pain control, nerve blocks reduce postoperative opioid requirements, thereby minimising opioid-related adverse effects and lowering the risk of pulmonary and cardiovascular complications.
This study aims to compare the postoperative analgesic effects of rectus sheath block and caudal epidural block in pediatric patients undergoing PIRS.
- Being tested
- Rectus Sheath Block, Caudal Epidural Block
- Keywords
- Percutaneous internal ring suturing, Rectus sheath block, Caudal epidural block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath BlockProcedure or surgery
A total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance.
Caudal Epidural BlockProcedure or surgery
A 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Block | Active comparator | Using an in-plane approach from cephalad to caudal, a 22G, 50-mm needle will be advanced through the subcutaneous tissues, penetrating the anterior rectus sheath and progressing within the muscle until the needle tip contacts the posterior rectus sheath. After negative aspiration, a total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance.
Paracetamol at a dose of 10 mg/kg will be administered intraoperatively. Receives: Procedure: Rectus Sheath Block |
| Caudal Epidural Block | Active comparator | A 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered.
Paracetamol at a dose of 10 mg/kg will be administered intraoperatively. Receives: Procedure: Caudal Epidural Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at rest and during coughing using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, scored from 0 to 10. Pain assessments will be performed at the 0th, 1st, 2nd, 4th, 12th, and 24th hours after surgery.
Measured: On the operation day
Secondary outcomes (2)
Postoperative nausea and vomiting
The occurrence of postoperative nausea and vomiting (PONV) and the number of episodes will be recorded.
Measured: On the operation day
Time to first mobilization
Time to first mobilization will be recorded in hours after surgery.
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start8 Sep 2025
- Primary completion13 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Internal Ring SuturingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Sule Ozdemir, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147062
- Sponsor's protocol ID
- AEŞH-EK-2025-170
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effects of Rectus Sheath Block and Caudal Epidural Block in Pediatric Patients Scheduled for Percutaneous Internal Ring Suturing
- ClinicalTrials.gov ID
- NCT07147062
- Acronym / sponsor ID
- AEŞH-EK-2025-170
- Keywords
- Percutaneous internal ring suturing, Rectus sheath block, Caudal epidural block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 13 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 28 Aug 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.
Inguinal hernia is one of the most common surgical pathologies in children, and the minimally invasive percutaneous internal ring suturing (PIRS) technique is widely preferred.
By providing effective pain control, nerve blocks reduce postoperative opioid requirements, thereby minimising opioid-related adverse effects and lowering the risk of pulmonary and cardiovascular complications.
This study aims to compare the postoperative analgesic effects of rectus sheath block and caudal epidural block in pediatric patients undergoing PIRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Block | Active comparator | Procedure: Rectus Sheath BlockUsing an in-plane approach from cephalad to caudal, a 22G, 50-mm needle will be advanced through the subcutaneous tissues, penetrating the anterior rectus sheath and progressing within the muscle until the needle tip contacts the posterior rectus sheath. After negative aspiration, a total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance. Paracetamol at a dose of 10 mg/kg will be administered intraoperatively. |
| Caudal Epidural Block | Active comparator | Procedure: Caudal Epidural BlockA 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered. Paracetamol at a dose of 10 mg/kg will be administered intraoperatively. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged between 1 and 8 years
- ASA physical status I-II
- Patients who underwent PIRS surgery in the operating room and received either a rectus sheath block or a caudal epidural block
Key exclusion criteria (3 listed)
- Patients younger than 1 year or older than 8 years
- ASA physical status ≥ III
- History of bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus Sheath BlockA total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance. | Procedure or surgery | Rectus Sheath Block |
| Caudal Epidural BlockA 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered. | Procedure or surgery | Caudal Epidural Block |
Primary outcome
Pain Scores
Time frame: On the operation day
Pain will be assessed at rest and during coughing using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, scored from 0 to 10. Pain assessments will be performed at the 0th, 1st, 2nd, 4th, 12th, and 24th hours after surgery.
2 secondary outcomes
Postoperative nausea and vomiting
Time frame: On the operation day
Time to first mobilization
Time frame: On the operation day
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 9 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus Sheath Block and Caudal Epidural Block in people with Percutaneous Internal Ring Suturing and Pain Management, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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 Elif Şule Özdemir Sezgi (00905059209638, elifsule-91@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: On the operation day). 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 9 Sep 2025.