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

Larissa University Hospital

Status: Unknown

Conditions: Shoulder Surgery; Ropivacaine; Interscalene Nerve Block

Treatments: Procedure: Interscalene nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT02125994

Shoulder 0.5 vs 0.375

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Ropivacaine 0.5%

Active Comparator group

Description:

Ultrasound guided Intercalene nerve block with ropivacaine 0.5 %

Treatment:

Procedure: Interscalene nerve block

Ropivacaine 0.375 %

Active Comparator group

Description:

Ultrasound guided Intercalene nerve block with ropivacaine 0.375 %

Treatment:

Procedure: Interscalene nerve block