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

Not Applicable

• Conditions: Interscalene Nerve Block; Shoulder Surgery; Ropivacaine
• Interventions: Procedure: Interscalene nerve block

• Registration Number: NCT02125994
• Lead Sponsor: Larissa University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-27
• Study First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Study First Posted: 2014-04-29
• Last Update Posted: 2014-04-29
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 0.5%	Interscalene nerve block	Ultrasound guided Intercalene nerve block with ropivacaine 0.5 %
Ropivacaine 0.375 %	Interscalene nerve block	Ultrasound guided Intercalene nerve block with ropivacaine 0.375 %

Primary Outcome Measures

Name	Time	Method
Blood pressure fluctuations	Completion of the surgery

Secondary Outcome Measures

Name	Time	Method
Heart rate fluctuations	Completion of surgery

Trial Locations

Locations (1)

Private Clinic of Larissa "Asklipeiio"; 🇬🇷 Larissa, Greece