Neurostimulation in Pudendal Nerve Block

Penile Surgery Clinical Trial

Official title:

Neurostimulation in Pudendal Nerve Block: is That Really Necessary?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072329
• Other study ID #: PNB-001
• Status: Completed
• Phase: N/A
• First received: February 25, 2017
• Last updated: March 6, 2017
• Start date: October 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: Hôpital d'enfants Béchir-Hamza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

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

Non-inclusion Criteria:

• Association to further peripheral nerve blocks required

Related Conditions & MeSH terms

• Penile Surgery

Intervention

Procedure:
• Pudendal nerve block

Drug:
• Bupivacaine

Locations

Country	Name	City	State
Tunisia	Hôpital d'Enfants Béchir Hamza	Bab Saadoun	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital d'enfants Béchir-Hamza

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve block success	Nerve block success is defined by the absence of 20% increase in heart rate or systolic blood pressure baseline values	15 minutes