EUCTR2011-002175-42-ATActive, not recruitingNot Applicable
The effect and safety of dexmedetomidine as an additive to ropivacaine for interscalene brachial plexus blocks for shoulder surgery
Paracelsus Medizinische Universität - Universitätsklinik für Anästhesie0 sitesStarted: September 5, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •ASA I-III adult subjects
- •Elective shoulder surgery
- •Plan for interscalene brachial plexus block combined with general anesthesia
- •Interscalene block placed between 7:00 a.m. and 12:00 a.m.
- •Willingness to be contacted postoperatively for brief (5-10 min) phone call
- •questionnaires
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Age < 18
- •Age > 65
- •Inability to understand protocol due to language barrier
- •Coagulation/bleeding disorders
- •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 > 3) daily average pain
- •Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin-norepinephrine
- •reuptake inhibitor, tramadol, corticosteroids
- •Hypersensitivity to amide local anesthetics
- •History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
- •Oxycodone allergy (oxycodone to be used for postoperative pain)
- •Uncontrolled anxiety
- •Schizophrenia or bipolar disorder
- •Preexisting nerve damage (sensory or motor) in the extremity to be blocked
- •Peripheral neuropathy
- •Significant respiratory disease (chronic obstructive pulmonary disease or asthma
- •requiring daily therapy)
- •Significant cardiovascular disease (second or third degree heart block, congestive heart
- •failure, symptomatic coronary artery disease)
- •BMI > 35
- •Uncontrolled diabetes (blood sugar > 250 recorded in last month)
- •Chronic clonidine therapy (clonidine patch – Catapres or clonidine tablets)
- •Hepatic Impairment
- •Renal Impairment
- •Ongoing drug or alcohol abuse
- •Local cutaneous infection at site of nerve block placement
- •Hearing impairment
- •Pregnancy
- •Prisoners
Investigators
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