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

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ClinicalTrials.gov Identifier: NCT02005575
Recruitment Status : Unknown
Verified February 2015 by dermot Maher, Cedars-Sinai Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
dermot Maher, Cedars-Sinai Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Post Minimally Invasive Thorascopic Surgical Pain Drug: Bupivacaine and Dexamethasone Drug: Placebo Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade
Study Start Date : October 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015


Arm Intervention/treatment
Placebo Comparator: Group 1
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline)
Drug: Placebo
Active Comparator: Group 2
an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone)
Drug: Bupivacaine and Dexamethasone
The standard of care is to use a regional block solution containing both decadron and bupivicaine.
Other Name: Decadron




Primary Outcome Measures :
  1. Post operative pain [ Time Frame: 72 hours post operatively ]
    Patients will be evaluated for post operative pain using the NRS pain evaulation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005575


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center

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Responsible Party: dermot Maher, Resident Department of Anesthesia, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02005575     History of Changes
Other Study ID Numbers: Pro00032069
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents