Effect of the Side of Interscalene Block on Bradycardia and Hypotension in Beach Chair Position
The Effect of the Side of Interscalene Block on the Occurrence of Bradycardia and Hypotension During Shoulder Surgery in the Beach Chair Position
1 other identifier
observational
50
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 10, 2014
July 1, 2014
2.1 years
December 19, 2012
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Interscalene block and beach chair positioning
Effect of interscalene block on hypotension and bradycardia during beach chair positioning
Intraoperatively
Study Arms (2)
Left interscalene block
Left interscalene block on hypotension and bradycardia during beach chair positioning
Right interscalene block
Right interscalene block on hypotension and bradycardia during beach chair positioning
Interventions
Eligibility Criteria
Patients for elective shoulder surgery
You may qualify if:
- elective shoulder surgery
- Age 50- 80 years old
- ASA II - IV
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Larissa University Hospital
Larissa, Thessally, 41110, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Simaioforidou, MD
Larissa University Hospital
- STUDY DIRECTOR
George Vretzakis, Medicine
Larissa University Hospital
- STUDY CHAIR
Katerina Tsiaka, Medicine
Larissa University Hospital
- STUDY CHAIR
George Basdekis, Medicine
Larissa University Hospital
- STUDY CHAIR
Athanasios Drakos, Medicine
Larissa University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 24, 2012
Study Start
December 1, 2012
Primary Completion
January 1, 2015
Study Completion
July 1, 2015
Last Updated
July 10, 2014
Record last verified: 2014-07