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Neurostimulation in Pudendal Nerve Block

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ClinicalTrials.gov Identifier: NCT03072329
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

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

Non-inclusion Criteria:

  • Association to further peripheral nerve blocks required
Contacts and Locations
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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): NCT03072329


Locations
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Tunisia
Hôpital d'Enfants Béchir Hamza
Bab Saadoun, Tunis, Tunisia, 1029
Sponsors and Collaborators
Hôpital d'enfants Béchir-Hamza
Investigators
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Principal Investigator: Ben Khalifa Sonia, PhD
More Information
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Responsible Party: Dr Sonia ben khalifa (PhD), Head of Anesthesia and Intensive Care Department, Hôpital d'enfants Béchir-Hamza
ClinicalTrials.gov Identifier: NCT03072329    
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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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents