Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery

NCT04668183 | Completed

• 1 other identifier: 1457
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Hypospadias

Keywords

Postoperative pain; Ultrasound; Dorsal penile nerve block; Pudendal nerve block; Hypospadias

Outcome Measures

Primary Outcomes (1)

• Time of Postoperative analgesic requirement

  It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher.

  Up to 24 hours

Secondary Outcomes (3)

• Level of Postoperative pain

  Up to 24 hours]

• Rate of Postoperative complications

  Up to 24 hours

• Level of Parent satisfaction

  Up to 24 hours

Study Arms (2)

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.

Procedure: Pudendal nerve block group

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.

Procedure: Dorsal penile nerve block group

Interventions

Pudendal nerve block group PROCEDURE

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.

Pudendal Nerve Block

Dorsal penile nerve block group PROCEDURE

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

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32507565 BACKGROUND

• 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.

  PMID: 29858133 BACKGROUND

• 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.

  PMID: 27956108 BACKGROUND

MeSH Terms

Conditions

Hypospadias; Pain, Postoperative

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Volkan Ozen, MD

  Prof. Dr. Cemil Tascıoglu City Hospital, Istanbul, Şişli, Turkey, 34384

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)