Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position

July 9, 2014 updated by: Marina Simaioforidou, Larissa University Hospital

The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position

The Left interscalene block has a different effect on heart's autonomic nervous system, compared to Right interscalene block. This effect is evident on the occurrence of bradycardia and hypotension during shoulder surgery in the beach chair position

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

  • Greece
    • Thessally
      • Larissa, Thessally, Greece, 41110
        • Recruiting
        • Larissa University Hospital
        • 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

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients for elective shoulder surgery

Description

Inclusion Criteria:

  • elective shoulder surgery
  • Age 50- 80 years old
  • ASA II - IV

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Left interscalene block
Left interscalene block on hypotension and bradycardia during beach chair positioning
Other: Left interscalene block
Right interscalene block
Right interscalene block on hypotension and bradycardia during beach chair positioning
Other: Right interscalene block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interscalene block and beach chair positioning
Time Frame: Intraoperatively
Effect of interscalene block on hypotension and bradycardia during beach chair positioning
Intraoperatively

Collaborators and Investigators

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

Sponsor

Larissa University Hospital

Investigators

  • Study Chair: George Basdekis, Medicine, Larissa University Hospital
  • Study Chair: Athanasios Drakos, Medicine, Larissa University Hospital
  • Study Director: George Vretzakis, Medicine, Larissa University Hospital
  • Principal Investigator: Marina Simaioforidou, MD, Larissa University Hospital
  • Study Chair: Katerina Tsiaka, Medicine, Larissa University Hospital

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

December 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intrerscalene beach chair

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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