Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03496740

Enrollment

Registered

2018-04-12

Start date

2018-04-15

Completion date

2018-11-23

Last updated

2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative pain, Ultrasound, Dorsal Penile Nerve Block, Pudendal Block, Hypospadias

Brief summary

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

Interventions

PROCEDUREPenile Block

Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

PROCEDUREPudendal Block

Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

DRUGBupivacaine (Block Drug)

Block drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

1 Years to 10 Years

Healthy volunteers

Inclusion criteria

* 1 to 10 years of age * ASA I-II * Undergoing elective hypospadias surgery

Exclusion criteria

* infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * ASA III-IV * Patients with neurological disorders

Design outcomes

Primary

Measure	Time frame	Description
Time to first analgesic	postoperative 7 day	First need for rescue analgesic after the surgery will be recorded

Secondary

Measure	Time frame	Description
Pain Scores	postoperative 48 hour	FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026