Effects of Anesthetic Technique on NK Cells

Cedars-Sinai Medical Center

Status: Invitation-only

Conditions: Cancer; Pain; Anesthesia

Treatments: Drug: Bupivacaine + Fentanyl; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02669186

Pro00039201-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

'Bupivacaine + Fentanyl' (Opioid Group)

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine + Fentanyl

Bupivacaine (Local Anesthetic Group)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine