Anatomical Measurements of Pudendal Nerve Block in Children

NCT ID: NCT07348029

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-06-10

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Management Penile Surgery-Related Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Neurostimulation-Guided Pudendal Nerve Block

Intervention Type PROCEDURE

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.

Interventions

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Neurostimulation-Guided Pudendal Nerve Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Münevver Kayhan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Munevver Kayhan, Lecturer Doctor

Role: PRINCIPAL_INVESTIGATOR

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Pinar Kendigelen

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Ayse Cigdem Tutuncu, Professor Doctor

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Locations

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Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Munevver Kayhan, Lecturer Doctor

Role: CONTACT

02124143000

Pinar Kendigelen, Professor Doctor

Role: CONTACT

02124143000

Facility Contacts

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Munevver Kayhan, Lecturer Doctor

Role: primary

02124143000

References

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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.

Reference Type RESULT
PMID: 27501015 (View on PubMed)

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.

Reference Type RESULT
PMID: 30074928 (View on PubMed)

Other Identifiers

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ctf- pudental mesafe- 04

Identifier Type: -

Identifier Source: org_study_id

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