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Pudendal Block Versus Caudal Block for Hypospadias

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ClinicalTrials.gov Identifier: NCT02390388
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : August 26, 2015
Sponsor:
Collaborators:
Ayse Cigdem Tutuncu
Senol Emre
Fatis Altindas
Guner Kaya
Information provided by (Responsible Party):
pinar kendigelen, Istanbul University

Brief Summary:
The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

Condition or disease Intervention/treatment Phase
Pain Procedure: pudendal nerve block Procedure: caudal block Phase 4

Detailed Description:
In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: pudendal block group
nerve stimulated pudendal nerve block performed under general anesthesia
Procedure: pudendal nerve block
nerve stimulator-guided Pudendal block

Active Comparator: Caudal block group
caudal block performed under general anesthesia
Procedure: caudal block
caudal block




Primary Outcome Measures :
  1. postoperative pain intensity measure [ Time Frame: 24 hours ]
    pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.


Secondary Outcome Measures :
  1. time to to first use of analgesic [ Time Frame: 24 hours ]
  2. parental satisfaction [ Time Frame: 24 hours ]

    Parent satisfaction was scored as:

    1. definitely unsatisfied;
    2. satisfied;
    3. definitely satisfied.

  3. the incidence of side effects [ Time Frame: 24 hours ]
  4. intraoperative analgesic requirement [ Time Frame: intraoperative ]
    intraoperative remifentanil infusion requirement ( If heart rate and/or blood pressure increase 20% than first measure, we will start remifentanil infusion)

  5. postoperative total analgesic requirements [ Time Frame: 24 hours ]


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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-II
  • aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion Criteria:

  • history of allergic reactions to local anesthetics
  • rash or infection at the injection site
  • anatomical abnormality
  • bleeding diatheses, coagulopathy, liver diseases

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): NCT02390388


Sponsors and Collaborators
Istanbul University
Ayse Cigdem Tutuncu
Senol Emre
Fatis Altindas
Guner Kaya
Investigators
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Study Director: Guner Kaya, Prof. Istanbul University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: pinar kendigelen, M.D.(Anesthesiology Specialist), Istanbul University
ClinicalTrials.gov Identifier: NCT02390388     History of Changes
Other Study ID Numbers: 242890
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by pinar kendigelen, Istanbul University:
pudendal block
Hypospadias
caudal block
child
analgesia
Additional relevant MeSH terms:
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Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities