Effects of Anesthetic Technique on NK Cells

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity

Conditions
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Pain, Anesthesia, Cancer

Intervention / Treatment
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* Drug: Bupivacaine + Fentanyl
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Bupivacaine + Fentanyl' (Opioid Group)<br>Group 1 (opioid group) will receive 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. | Drug: Bupivacaine + Fentanyl<br>* 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.<br>* Other names: Sublimaze;|
| Active Comparator: Bupivacaine (Local Anesthetic Group)<br>Group 2 (local anesthetic group) will receive 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. | Drug: Bupivacaine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer Cell Cytotoxicty | Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression. | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, cancer, natural killer cell, opioid