Effects of Anesthetic Technique on NK Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Pain Anesthesia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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'Bupivacaine + Fentanyl' (Opioid Group)

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.

Group Type EXPERIMENTAL

Bupivacaine + Fentanyl

Intervention Type DRUG

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)

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Interventions

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Bupivacaine + Fentanyl

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.

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Sublimaze

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes