Clinical Use of Prilocaine Chlorhydrate Among a General S... | NCT02282280

Studies
Clinical Use of Prilocaine Chlorhydrate Among a General Surgical Population

NCT02282280

Sponsor

Astes

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

380Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Prilocaine Chlorhydrate

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 31, 2014

First Submission Date that Met QC Criteria

Oct 31, 2014

First Posted Date

Nov 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in rachianesthesia among a general surgical population.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

380Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		All patients included in the study	Drug: Prilocaine Chlorhydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prilocaine Chlorhydrate	Drug	Use of prilocaine in spinal anesthesia	Study Group

Measure	Description	Time Frame
Duration of action		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

500 consecutive patients with a spinal anesthesia

Exclusion Criteria:

Patient's refusal
Age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

500 consecutive patients with a spinal anesthesia with prilocaine at Clinique Saint-Luc de Bouge

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric P Deflandre, MD, FCCP	Astes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint-Luc Bouge		Namur	Namur	5004	Belgium