- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348029
Anatomical Measurements of Pudendal Nerve Block in Children
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: münevver kayhan, Lecturer Doctor
- Phone Number: 02124143000
- Email: munevver.kayhan@iuc.edu.tr
Study Contact Backup
- Name: Pinar Kendigelen, Professor Doctor
- Phone Number: 02124143000
- Email: pinarken@gmail.com
Study Locations
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Istanbul
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Bakırköy, Istanbul, Turkey (Türkiye), 34153
- Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
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Contact:
- münevver kayhan, Lecturer Doctor
- Phone Number: 02124143000
- Email: munevver.kayhan@iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Horizontal distance from anus to needle insertion point and Depth from skin surface to pudendal nerve
Time Frame: During pudendal nerve block procedure
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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.
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During pudendal nerve block procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: münevver kayhan, Lecturer Doctor, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
- Study Chair: Ayse Cigdem Tutuncu, Professor Doctor, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
- Study Chair: Pinar Kendigelen, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Publications and helpful links
General Publications
- Walker 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ctf- pudental mesafe- 04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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