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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02125994
Other study ID # Shoulder 0.5 vs 0.375
Secondary ID
Status Recruiting
Phase N/A
First received April 27, 2014
Last updated April 28, 2014
Start date March 2014
Est. completion date December 2015

Study information

Verified date April 2014
Source Larissa University Hospital
Contact Marina Simaioforidou, Medicine
Phone 0000306972202573
Email msimaiof@otenet.gr
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Interscalene nerve block


Locations

Country Name City State
Greece Private Clinic of Larissa "Asklipeiio" Larissa

Sponsors (1)

Lead Sponsor Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure fluctuations Completion of the surgery No
Secondary Heart rate fluctuations Completion of surgery No
See also
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