Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
NCT ID: NCT04668183
Last Updated: 2020-12-16
Study Results
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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COMPLETED
30 participants
OBSERVATIONAL
2019-11-01
2020-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Pudendal Nerve Block
Linear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone.
Pudendal nerve block group
A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
Dorsal Penile Nerve Block
Ultrasound (US) guided dorsal penile nerve block with in plane technique was done. Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
Dorsal penile nerve block group
Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
Interventions
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Pudendal nerve block group
A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
Dorsal penile nerve block group
Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) I-II group
* Distal hypospadias surgery
* Able to communicate in Turkish
* Willing to participate to the study (parents and children)
Exclusion Criteria
* A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
* Unwilling to to participate to the study ((parents or children)
1 Year
7 Years
MALE
Yes
Sponsors
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
OTHER
Responsible Party
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Volkan Ozen
MD
Principal Investigators
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Volkan Ozen, MD
Role: STUDY_DIRECTOR
Prof. Dr. Cemil Tascıoglu City Hospital, Istanbul, Şişli, Turkey, 34384
Locations
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Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.
Alizadeh F, Heydari SM, Nejadgashti R. Effectiveness of caudal epidural block on interaoperative blood loss during hypospadias repair: A randomized clinical trial. J Pediatr Urol. 2018 Oct;14(5):420.e1-420.e5. doi: 10.1016/j.jpurol.2018.03.025. Epub 2018 May 21.
Saavedra-Belaunde JA, Soto-Aviles O, Jorge J, Escudero K, Vazquez-Cruz M, Perez-Brayfield M. Can regional anesthesia have an effect on surgical outcomes in patients undergoing distal hypospadia surgery? J Pediatr Urol. 2017 Feb;13(1):45.e1-45.e4. doi: 10.1016/j.jpurol.2016.09.011. Epub 2016 Oct 26.
Other Identifiers
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1457
Identifier Type: -
Identifier Source: org_study_id