Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervou... | NCT02125994

Studies
Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System

NCT02125994

Sponsor

Larissa University Hospital

Status

Unknown status

Last Update Posted

Apr 29, 2014Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Shoulder Surgery
Interscalene Nerve Block
Ropivacaine

Interventions

Interscalene nerve block

Countries

Greece

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Oct 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Apr 27, 2014

First Submission Date that Met QC Criteria

Apr 28, 2014

First Posted Date

Apr 29, 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

Apr 28, 2014

Last Update Posted Date

Apr 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marina Simaioforidou, Anesthesiologist, Larissa University HospitalPrincipal Investigator

Lead Sponsor

Larissa University HospitalOTHER

Collaborators

Not provided

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

It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.

The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine 0.5%	Active Comparator	Ultrasound guided Intercalene nerve block with ropivacaine 0.5 %	Procedure: Interscalene nerve block
Ropivacaine 0.375 %	Active Comparator	Ultrasound guided Intercalene nerve block with ropivacaine 0.375 %	Procedure: Interscalene nerve block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interscalene nerve block	Procedure		Ropivacaine 0.375 % Ropivacaine 0.5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure fluctuations		Completion of the surgery

Secondary Outcomes

Measure	Description	Time Frame
Heart rate fluctuations		Completion of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective shoulder surgery
Age 18- 80 years old
ASA I - IV
Beach chair position

Exclusion Criteria:

Coagulopathy disorders
Infection at the puncture site for the interscalene block
Neurological deficit on the side to be operated
Allergy to local anesthetics
Psychiatric disorders
Patient's refusal
Problems with patient communication
Failure of the interscalene block

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marina Simaioforidou, Medicine	Contact	0000306972202573		msimaiof@otenet.gr

Overall Officials

Name	Affiliation	Role
Marina Simaioforidou, Medicine	Private Clinic of Larissa "Asklipeiio"	Study Director
Metaxia Bareka, Medicine	University Hospital of Larisa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Private Clinic of Larissa "Asklipeiio"	Recruiting	Larissa	Larissa		Greece