NCT03072329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

February 25, 2017

Last Update Submit

March 6, 2017

Conditions

Penile Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pudendal nerve block

EXPERIMENTAL

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

Procedure: Pudendal nerve blockDrug: Bupivacaine

Interventions

Pudendal nerve blockPROCEDURE
Pudendal nerve block
BupivacaineDRUG
Pudendal nerve block

Eligibility Criteria

Age6 Months+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children scheduled for elective penile surgery (hypospadias / circumcision)
  • Association to further peripheral nerve blocks required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital d'Enfants Béchir Hamza

Bab Saadoun, Tunis Governorate, 1029, Tunisia

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ben Khalifa Sonia, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia and Intensive Care Department

Study Record Dates

First Submitted

February 25, 2017

First Posted

March 7, 2017

Study Start

October 1, 2016

Primary Completion

February 20, 2017

Study Completion

March 1, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)