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Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

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ClinicalTrials.gov Identifier: NCT03496740
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Can AKSU, Kocaeli University

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Penile Block Procedure: Pudendal Block Drug: Bupivacaine (Block Drug) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : November 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Bupivacaine

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
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)

Drug: Bupivacaine (Block Drug)
Block drug




Primary Outcome Measures :
  1. Time to first analgesic [ Time Frame: postoperative 7 day ]
    First need for rescue analgesic after the surgery will be recorded


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male patients undergoing elective hypospadias surgery
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496740


Locations
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Turkey
Kocaeli University Hospital
İzmit, Kocaeli, Turkey, 41340
Sponsors and Collaborators
Kocaeli University

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Responsible Party: Can AKSU, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03496740     History of Changes
Other Study ID Numbers: 2017-379
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Can AKSU, Kocaeli University:
Postoperative pain
Ultrasound
Dorsal Penile Nerve Block
Pudendal Block
Hypospadias
Additional relevant MeSH terms:
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Hypospadias
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents