Clinical trial NCT04668183: Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Official title: Ultrasound-guided Pudendal Nerve Block Versus Ultrasound-guided Dorsal Penile Nerve Block for Pediatric Distal Hypospadias Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia
Hypospadias
Keywords: Postoperative pain
Ultrasound
Dorsal penile nerve block
Pudendal nerve block
Hypospadias
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 30
Sex: MALE
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted with children who underwent hypospadias surgery at a training and research hospital in Istanbul, Turkey.

Brief summary: Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.

Detailed description: The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.

Eligibility criteria: Inclusion Criteria:

* Male patients aged between 1-7 years
* 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:

* Less than 1 or more than 7 years of age
* 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)

Primary outcomes:
measure: Time of Postoperative analgesic requirement
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Level of Postoperative pain
timeFrame: Up to 24 hours]
measure: Rate of Postoperative complications
timeFrame: Up to 24 hours
measure: Level of Parent satisfaction
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital, Istanbul, Şişli, Turkey, 34384
name: Volkan Ozen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.