Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

November 23, 2018 updated by: Can AKSU, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocaeli
      • İzmit, Kocaeli, Turkey, 41340
        • Kocaeli University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Penile Block

Ultrasound guided dorsal penile nerve block will be administered after general anesthesia.

0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks
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)
Drug: Bupivacaine (Block Drug)
Block drug
Active Comparator: Pudendal Block
Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks
Drug: Bupivacaine (Block Drug)
Block drug
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: 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.
postoperative 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Actual)

November 23, 2018

Study Completion (Actual)

November 23, 2018

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 23, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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