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

NCT ID: NCT02005575

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-03-31

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.

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.

Conditions

Post Minimally Invasive Thorascopic Surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Group 2

an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone)

Group Type: ACTIVE_COMPARATOR

Bupivacaine and Dexamethasone

Intervention Type: DRUG

The standard of care is to use a regional block solution containing both decadron and bupivicaine.

Interventions

Bupivacaine and Dexamethasone

The standard of care is to use a regional block solution containing both decadron and bupivicaine.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Decadron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

dermot Maher

Resident Department of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Pro00032069

Identifier Type: -

Identifier Source: org_study_id