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

April 28, 2014 updated by: Marina Simaioforidou, Larissa University Hospital

Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marina Simaioforidou, Medicine
  • Phone Number: 0000306972202573
  • Email: msimaiof@otenet.gr

Study Locations

  • Greece
      • Larissa, Greece
        • Recruiting
        • Private Clinic of Larissa "Asklipeiio"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaine 0.5%
Ultrasound guided Intercalene nerve block with ropivacaine 0.5 %
Procedure: Interscalene nerve block
Active Comparator: Ropivacaine 0.375 %
Ultrasound guided Intercalene nerve block with ropivacaine 0.375 %
Procedure: Interscalene nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure fluctuations
Time Frame: Completion of the surgery
Completion of the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate fluctuations
Time Frame: Completion of surgery
Completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Investigators

  • Study Chair: Konstantinos Alexiou, Medicine, Larissa University Hospital
  • Study Director: Marina Simaioforidou, Medicine, Private Clinic of Larissa "Asklipeiio"
  • Principal Investigator: Metaxia Bareka, Medicine, University Hospital Of Larisa
  • Study Chair: George Basdekis, Medicine, Private Clinic of Larissa "Asklipeiio"
  • Study Chair: Konstantinos Bargiotas, Medicine, Larissa University Hospital
  • Study Chair: Sokrates Varitimidis, Medicine, Larissa University Hospital
  • Study Chair: Aristeidis Zibis, Medicine, Private Clinic of Larissa "Asklipeiio"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 27, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Shoulder 0.5 vs 0.375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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