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

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.

Study Overview

• Status: Unknown
• Conditions: Post Minimally Invasive Thorascopic Surgical Pain
• Intervention / Treatment: Drug: Placebo; Drug: Bupivacaine and Dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	Patients will be evaluated for post operative pain using the NRS pain evaulation	72 hours post operatively

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2015
• Study Completion (ANTICIPATED): March 1, 2015

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (ESTIMATE): December 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: Pro00032069