Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Peter Gerner, M.D.
• Treatments: Dexmedetomidine; Ropivacaine

Criteria

Inclusion Criteria:

• ASA I-III adult subjects

• Age 18-75

• Elective shoulder surgery

• Plan for interscalene brachial plexus block combined with general anesthesia

• Interscalene block

• Willingness to be contacted postoperatively for brief (5-10min) phone call questionnaires

• Written informed consent

Exclusion Criteria:

• Age < 18

• Age > 75

• Inability to understand protocol due to language barrier; difficulty with German language

• Chronic pain requiring daily opioids > 15 mg oral morphine equivalents (equals oral usage of > 10 mg oxycodone/daily; > 5 mg methadone/day; > 4 mg hydromorphone/day)

• Moderate (NRS pain score > 5) daily average pain

• Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin- norepinephrine reuptake inhibitor, tramadol

• Hypersensitivity to amide local anesthetics

• History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine

• Uncontrolled anxiety

• Schizophrenia or bipolar disorder

• Preexisting nerve damage (sensory or motor) in the extremity to be blocked

• Peripheral neuropathy

• Significant cardiovascular disease (second (Mobitz II type) or third degree heart block, congestive heart failure, chronic heart failure NYHA III-IV, symptomatic coronary artery disease CSS III-IV)

• BMI > 35

• Uncontrolled diabetes (blood sugar > 250 recorded in last 30 days or HbA1c > 7.5%)

• Chronic clonidine therapy (clonidine patch - Catapres or clonidine tablets)

• Hepatic Impairment (CHILD B or higher)

• Renal Impairment (creatinin > 2.0 mg/dl)

• Ongoing drug or alcohol abuse

• Pregnancy

• Prisoners