Anesthesia, Cancer, Pain
Conditions
Keywords
analgesia, cancer, natural killer cell, opioid
Brief summary
The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.
Interventions
General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
DRUGBupivacaine
General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 - 80 years old of either gender * Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon * Must be able to have an epidural
Exclusion criteria
* ASA IV and above * Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine. * Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months) * Uncontrolled hypertension (BP \> 140/90) * 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) * Neuropathic pain * Chronic opioid consumption (\>30mg oxycodone or greater per day) * Cachexia from any cause * Systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery * HIV or other immunosuppressive condition * Preoperative INR \> 1.4 or platelet count \< 100 * Sepsis or overlying skin cellulitis at epidural catheter insertion site * Inability to tolerate/unwillingness to have an epidural catheter for intraoperative/postoperative pain control for any reason, including prior back surgery resulting in distorted anatomy that precludes neuraxial anesthesia. * Inability to tolerate an epidural solution of either fentanyl or bupivacaine or needs another form of specialized pain control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natural Killer Cell Cytotoxicty | One Year | Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression. |
Countries
United States
Outcome results
None listed