The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 18 - 80 years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.

Exclusion Criteria:

• ASA IV and above

• Intolerance, allergy, or contraindication to use of any medications used in this study

• Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)

• Uncontrolled hypertension (BP > 140/90)

• History of prior ipsilateral thorascopic surgery

• Cardiac arrhythmias particularly prolonged QT syndrome

• Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants

• Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis

• Pregnant or lactating women

• Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg

• Chronic renal failure ( creatinine > 2.0 mg/dL)

• Liver failure e.g., active cirrhosis

• Alcohol or substance abuse within in the past 3 months

• Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)

• Restrictive lung disease (pulmonary fibrosis, myasthenia gravis) or FEV1 or FEV less than 70% of predicted value.

• Type 2 diabetes

• Neuropathic pain

• Chronic opioid consumption (>30mg oxycodone or greater per day)

• Cahexia from any cause

• systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery