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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02005575

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

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 Names: Decadron

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 Names:

Decadron

Outcome Measures

Primary Outcome Measures

Post operative pain [72 hours post operatively]
Patients will be evaluated for post operative pain using the NRS pain evaulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

dermot Maher, Resident Department of Anesthesia, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT02005575

Other Study ID Numbers:

Pro00032069

First Posted:

Dec 9, 2013

Last Update Posted:

Feb 4, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Dexamethasone

Bupivacaine

Study Results

No Results Posted as of Feb 4, 2015