Overview

This trial is active, not recruiting.

Condition post minimally invasive thorascopic surgical pain
Treatments bupivacaine and dexamethasone, placebo
Phase phase 4
Sponsor Cedars-Sinai Medical Center
Start date October 2013
End date March 2015
Trial size 50 participants
Trial identifier NCT02005575, Pro00032069

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline)
placebo
(Active Comparator)
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone)
bupivacaine and dexamethasone Decadron
The standard of care is to use a regional block solution containing both decadron and bupivicaine.

Primary Outcomes

Measure
Post operative pain
time frame: 72 hours post operatively

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade
Description Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Cedars-Sinai Medical Center.