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

Post Minimally Invasive Thorascopic Surgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02005575
• Other study ID #: Pro00032069
• Status: Unknown status
• Phase: Phase 4
• First received: November 5, 2013
• Last updated: February 2, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Minimally Invasive Thorascopic Surgical Pain

Intervention

Drug:
• Bupivacaine and Dexamethasone
The standard of care is to use a regional block solution containing both decadron and bupivicaine.
• Placebo

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Patients will be evaluated for post operative pain using the NRS pain evaulation	72 hours post operatively