Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System
Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 29, 2014
April 1, 2014
1.6 years
April 27, 2014
April 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Blood pressure fluctuations
Completion of the surgery
Secondary Outcomes (1)
Heart rate fluctuations
Completion of surgery
Study Arms (2)
Ropivacaine 0.5%
ACTIVE COMPARATORUltrasound guided Intercalene nerve block with ropivacaine 0.5 %
Ropivacaine 0.375 %
ACTIVE COMPARATORUltrasound guided Intercalene nerve block with ropivacaine 0.375 %
Interventions
Eligibility Criteria
You may qualify if:
- Elective shoulder surgery
- Age 18- 80 years old
- ASA I - IV
- Beach chair position
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)
Private Clinic of Larissa "Asklipeiio"
Larissa, Larissa, Greece
Study Officials
- 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 CHAIR
Konstantinos Alexiou, Medicine
Larissa University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
April 27, 2014
First Posted
April 29, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
April 29, 2014
Record last verified: 2014-04