Neurostimulation in Pudendal Nerve Block

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: Penile Surgery
• Intervention / Treatment: Drug: Bupivacaine; Procedure: Pudendal nerve block

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

• Sponsor: Hôpital d'enfants Béchir-Hamza
• Investigators: Principal Investigator: Ben Khalifa Sonia, PhD

Study record dates

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: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PNB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No