Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496740
• Other study ID #: 2017-379
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: November 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypospadias
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Penile 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)
• Pudendal 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)

Drug:
• Bupivacaine (Block Drug)
Block drug

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Izmit	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first analgesic	First need for rescue analgesic after the surgery will be recorded	postoperative 7 day
Secondary	Pain Scores	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.	postoperative 48 hour