Effects of Anesthetic Technique on NK Cells

Not Applicable

• Conditions: Cancer; Anesthesia; Pain
• Interventions: Drug: Bupivacaine + Fentanyl; Drug: Bupivacaine

• Registration Number: NCT02669186
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2019-07-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Bupivacaine + Fentanyl' (Opioid Group)	Bupivacaine + Fentanyl	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.
Bupivacaine (Local Anesthetic Group)	Bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Natural Killer Cell Cytotoxicty	One Year	Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States