Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System

Shoulder Surgery Clinical Trial

Official title:

Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02125994
• Other study ID #: Shoulder 0.5 vs 0.375
• 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

• Interscalene Nerve Block
• Ropivacaine
• Shoulder Surgery

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