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Neurostimulation in Pudendal Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03072329
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):
Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza

Brief Summary:
The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.

Condition or disease Intervention/treatment Phase
Penile Surgery Procedure: Pudendal nerve block Drug: Bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurostimulation in Pudendal Nerve Block: is That Really Necessary?
Study Start Date : October 2016
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Pudendal nerve block
Bilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response.
Procedure: Pudendal nerve block
Drug: Bupivacaine

Primary Outcome Measures :
  1. Nerve block success [ Time Frame: 15 minutes ]
    Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children scheduled for elective penile surgery (hypospadias / circumcision)

Non-inclusion Criteria:

  • Association to further peripheral nerve blocks required

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 identifier (NCT number): NCT03072329

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Hôpital d'Enfants Béchir Hamza
Bab Saadoun, Tunis, Tunisia, 1029
Sponsors and Collaborators
Hôpital d'enfants Béchir-Hamza
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Principal Investigator: Ben Khalifa Sonia, PhD

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Responsible Party: Dr Sonia ben khalifa (PhD), Head of Anesthesia and Intensive Care Department, Hôpital d'enfants Béchir-Hamza Identifier: NCT03072329     History of Changes
Other Study ID Numbers: PNB-001
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents