Postoperative Pain ManagementNCT07348029
Anatomical Measurements of Pudendal Nerve Block in Children
An observational study of Postoperative Pain Management and Penile Surgery-Related Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the relationship between anatomical parameters-specifically the distance from the anus to the needle insertion point and the depth required to reach the pudendal nerve-during neurostimulation-guided pudendal nerve block and patients' age, height, and weight in… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Postoperative Pain Management, Penile Surgery-Related Pain
- What is being tested?
- Neurostimulation-Guided Pudendal Nerve Block
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 10 Jun 2026
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study includes children aged 1-18 years who are undergoing penile surgery. Neurostimulation-guided pudendal nerve block will be performed, and anatomical measurements, including the horizontal distance from the anus to the needle insertion point and the depth from the skin to the pudendal nerve, will be recorded. Measurements will be taken separately for the right and left sides. Patient age, height, and weight will also be recorded, and their relationship with the anatomical measurements will be analyzed. The study will be conducted at Istanbul University-Cerrahpasa, Department of Pediatric Surgery.
Who may be able to join
- Children aged 1-18 years
- Scheduled for penile surgery (e.g., hypospadias, phimosis)
- Planned to receive neurostimulation-guided pudendal nerve block
- Patient and parents/legal guardians willing to participate under general anesthesia
Who cannot join
- Patients with incomplete measurement data
- Cases where successful nerve block cannot be performed or nerve stimulation is not detectable at currents ≥1.5 mA
- Patients or parents/legal guardians who refuse pudendal nerve block
- Patients with pelvic deformities or neuromuscular disorders
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
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Bakırköy, Istanbul, 34153
Munevver Kayhan, Lecturer Doctor, 02124143000, munevver.kayhan@iuc.edu.tr
About this study
Official title: Investigation of the Distance of the Needle Entry Point From the Anus and the Depth to Reach the Pudendal Nerve in Pudendal Nerve Block Application in Children
This prospective observational study aims to investigate the relationship between anatomical parameters-specifically the distance from the anus to the needle insertion point and the depth required to reach the pudendal nerve-during neurostimulation-guided pudendal nerve block and patients' age, height, and weight in children undergoing penile surgery.
Read the detailed description
The pudendal nerve originates from the sacral nerve roots Sacral2-Sacral4 and provides sensory and motor innervation to the penile and perineal regions. Effective postoperative analgesia is essential in pediatric penile surgeries. Pudendal nerve block may provide longer-lasting and more effective analgesia compared to caudal or penile blocks.
However, due to age- and size-related anatomical variability in children, data regarding optimal needle insertion distance and depth to reach the pudendal nerve are limited. In this study, neurostimulation will be used to confirm pudendal nerve localization, and anatomical measurements will be analyzed in relation to demographic parameters.
- Being tested
- Neurostimulation-Guided Pudendal Nerve Block
- Keywords
- Pudendal Nerve Block, Pediatric Regional Anesthesia, Neurostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation-Guided Pudendal Nerve BlockProcedure or surgery
Bilateral pudendal nerve block is performed under general anesthesia with neurostimulation guidance. Anatomical measurements, including distance from anus to needle insertion point and nerve depth, are recorded for each patient. Bupivacaine 0.25% is used at 0.25 ml/kg per side, with a maximum total dose of 2 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Penile Surgery Cohort | Children aged 1-18 years undergoing penile surgery with neurostimulation-guided pudendal nerve block; anatomical measurements of needle insertion distance from anus and nerve depth are recorded. Receives: Procedure: Neurostimulation-Guided Pudendal Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal distance from anus to needle insertion point and Depth from skin surface to pudendal nerve
The horizontal distance from the anus to the needle insertion point is measured in centimeters for each patient using neurostimulation-guided pudendal nerve block. Measurements are recorded separately for the right and left sides.The depth from the skin surface to the pudendal nerve is measured in centimeters using neurostimulation guidance. Measurements are recorded separately for the right and left sides. The relationship of this distance and the association of nerve depth with patient age, height, and weight will be analyzed.
Measured: During pudendal nerve block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
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 Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Münevver Kayhan, Istanbul University - Cerrahpasa
- Investigators
- Munevver Kayhan, Lecturer Doctor, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyPinar Kendigelen, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyAyse Cigdem Tutuncu, Professor Doctor, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348029
- Sponsor's protocol ID
- ctf- pudental mesafe- 04
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PubMed 27501015Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
PubMed 30074928
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Distance of the Needle Entry Point From the Anus and the Depth to Reach the Pudendal Nerve in Pudendal Nerve Block Application in Children
- ClinicalTrials.gov ID
- NCT07348029
- Acronym / sponsor ID
- ctf- pudental mesafe- 04
- Keywords
- Pudendal Nerve Block, Pediatric Regional Anesthesia, Neurostimulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 16 Jan 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 prospective observational study aims to investigate the relationship between anatomical parameters-specifically the distance from the anus to the needle insertion point and the depth required to reach the pudendal nerve-during neurostimulation-guided pudendal nerve block and patients' age, height, and weight in children undergoing penile surgery.
Detailed description
The pudendal nerve originates from the sacral nerve roots Sacral2-Sacral4 and provides sensory and motor innervation to the penile and perineal regions. Effective postoperative analgesia is essential in pediatric penile surgeries. Pudendal nerve block may provide longer-lasting and more effective analgesia compared to caudal or penile blocks.
However, due to age- and size-related anatomical variability in children, data regarding optimal needle insertion distance and depth to reach the pudendal nerve are limited. In this study, neurostimulation will be used to confirm pudendal nerve localization, and anatomical measurements will be analyzed in relation to demographic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Penile Surgery Cohort | – | Procedure: Neurostimulation-Guided Pudendal Nerve BlockChildren aged 1-18 years undergoing penile surgery with neurostimulation-guided pudendal nerve block; anatomical measurements of needle insertion distance from anus and nerve depth are recorded. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study includes children aged 1-18 years who are undergoing penile surgery. Neurostimulation-guided pudendal nerve block will be performed, and anatomical measurements, including the horizontal distance from the anus to the needle insertion point and the depth from the skin to the pudendal nerve, will be recorded. Measurements will be taken separately for the right and left sides. Patient age, height, and weight will also be recorded, and their relationship with the anatomical measurements will be analyzed. The study will be conducted at Istanbul University-Cerrahpasa, Department of Pediatric Surgery.
Key inclusion criteria (4 listed)
- Children aged 1-18 years
- Scheduled for penile surgery (e.g., hypospadias, phimosis)
- Planned to receive neurostimulation-guided pudendal nerve block
- Patient and parents/legal guardians willing to participate under general anesthesia
Key exclusion criteria (4 listed)
- Patients with incomplete measurement data
- Cases where successful nerve block cannot be performed or nerve stimulation is not detectable at currents ≥1.5 mA
- Patients or parents/legal guardians who refuse pudendal nerve block
- Patients with pelvic deformities or neuromuscular disorders
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 |
|---|---|---|
| Neurostimulation-Guided Pudendal Nerve BlockBilateral pudendal nerve block is performed under general anesthesia with neurostimulation guidance. Anatomical measurements, including distance from anus to needle insertion point and nerve depth, are recorded for each patient. Bupivacaine 0.25% is used at 0.25 ml/kg per side, with a maximum total dose of 2 mg/kg. | Procedure or surgery | Pediatric Penile Surgery Cohort |
Primary outcome
Horizontal distance from anus to needle insertion point and Depth from skin surface to pudendal nerve
Time frame: During pudendal nerve block procedure
The horizontal distance from the anus to the needle insertion point is measured in centimeters for each patient using neurostimulation-guided pudendal nerve block. Measurements are recorded separately for the right and left sides.The depth from the skin surface to the pudendal nerve is measured in centimeters using neurostimulation guidance. Measurements are recorded separately for the right and left sides. The relationship of this distance and the association of nerve depth with patient age, height, and weight will be analyzed.
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 16 Jan 2026.
- Results publication: PubMed 27501015Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
- Results publication: PubMed 30074928Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
- Individual participant dataSharing planned: No
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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.
Munevver Kayhan, Lecturer Doctor principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Pinar Kendigelen study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Ayse Cigdem Tutuncu, Professor Doctor study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
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 Postoperative Pain Management and Penile Surgery-Related Pain, run by Istanbul University - Cerrahpasa 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Jan 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 Munevver Kayhan, Lecturer Doctor (02124143000, munevver.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal distance from anus to needle insertion point and Depth from skin surface to pudendal nerve (time frame: During pudendal nerve block procedure). 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 NCT07348029, 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 16 Jan 2026.