Neurostimulation in Pudendal Nerve Block

March 6, 2017 updated by: Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza

Neurostimulation in Pudendal Nerve Block: is That Really Necessary?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Tunis
      • Bab Saadoun, Tunis, Tunisia, 1029
        • Hopital d'Enfants Bechir Hamza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Non-inclusion Criteria:

  • Association to further peripheral nerve blocks required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Bupivacaine
Procedure: Pudendal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital d'enfants Béchir-Hamza

Investigators

  • Principal Investigator: Ben Khalifa Sonia, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

February 20, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNB-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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