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

This study is currently recruiting participants.
Verified December 2012 by Larissa University Hospital
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01755780
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention
Shoulder Surgery
Beach Chair Position
Interscalene Block
Hypotension
Bradycardia
Autonomic Nervous System
 Other: Left interscalene block
Other: Right interscalene block

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Interscalene block and beach chair positioning [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
    Effect of interscalene block on hypotension and bradycardia during beach chair positioning


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients for elective shoulder surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755780

Contacts
Contact: Marina Simaioforidou, Medicine 00306972202573 msimaiof@otenet.gr
Contact: George Vretzakis, Medicine 00302413502952 gvretzakis@yahoo.com

Locations
Greece
Larissa University Hospital Recruiting
Larissa, Thessally, Greece, 41110
Contact: George Vretzakis, Medicine     00302413502952     gvretzakis@yahoo.com    
Sponsors and Collaborators
Larissa University Hospital
  More Information

No publications provided

Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755780     History of Changes
Other Study ID Numbers: Intrerscalene beach chair
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Hypotension
Bradycardia
Vascular Diseases
Cardiovascular Diseases
 Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013