Neurostimulation in Pudendal Nerve Block

Not Applicable

Completed

• Conditions: Penile Surgery
• Interventions: Procedure: Pudendal nerve block; Drug: Bupivacaine

• Registration Number: NCT03072329
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-02-20
• Study First Submitted: 2017-02-25
• Status Verified: 2017-03
• Study Completion: 2017-03-01
• Study First Submitted QC: 2017-03-06
• Last Update Submitted: 2017-03-06
• Study First Posted: 2017-03-07
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

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

Non-inclusion Criteria:

• Association to further peripheral nerve blocks required

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pudendal nerve block	Pudendal nerve block	Bilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response.
Pudendal nerve block	Bupivacaine	Bilateral pudendal nerve block with the administration of 0.1 mL/kg Bupivacaïne 0.5%, regardless of neurostimulation response.

Primary Outcome Measures

Name	Time	Method
Nerve block success	15 minutes	Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values

Trial Locations

Locations (1)

Hôpital d'Enfants Béchir Hamza; 🇹🇳 Bab Saadoun, Tunis, Tunisia