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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Post Minimally Invasive Thorascopic Surgical Pain

In brief

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.

Key facts

Study ID

NCT02005575

Run by

Cedars-Sinai Medical Center

People needed

50

Starts

2013-10-01

Expected to finish

2015-03-01

Last updated by the study team

2015-02-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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