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Local Anesthetic

Anesthetic Techniques for Pain and Anesthesia

N/A

Waitlist Available

Led By Roya Yumul, MD, PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon

Must be able to have an epidural

Must not have

Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg

HIV or other immunosuppressive condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two anesthetic techniques on natural killer cells in patients undergoing abdominal surgery.

Who is the study for?

This trial is for adults aged 18-80 with an abdominal tumor scheduled for exploratory surgery, who can have an epidural. It's not for those with severe health issues like heart disease, uncontrolled high blood pressure, significant psychological disorders, or certain medication use. Pregnant women and individuals with obesity or organ failure are also excluded.

What is being tested?

The study compares the effects of two anesthesia methods using Bupivacaine alone versus Bupivacaine combined with Fentanyl on natural killer cells in patients having abdominal surgery. It's a pilot study where participants are randomly assigned to one of these standard treatments without knowing which one they receive.

What are the potential side effects?

Possible side effects from the interventions may include typical reactions to local anesthetics such as numbness, weakness, low blood pressure, and nausea. Fentanyl might cause drowsiness, nausea, confusion or respiratory depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to explore my abdominal tumor.

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I can have an epidural.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a BMI over 40 or weigh more than 150 kg.

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I have HIV or another condition that weakens my immune system.

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I am allergic or cannot tolerate fentanyl or bupivacaine.

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My blood pressure is not higher than 140/90.

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I have a heart condition known as prolonged QT syndrome.

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I am not taking medications known to affect heart rhythm.

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I do not have active liver failure or cirrhosis.

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My blood levels of potassium, magnesium, or calcium are low and not corrected.

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I take more than 30mg of oxycodone or equivalent daily.

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I am experiencing significant weight loss and muscle wasting.

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I have used corticosteroids for more than 2 weeks in the last 6 months.

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I do not have an infection or skin issue where my epidural was placed.

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I cannot or do not want to have an epidural for pain control due to back issues or personal choice.

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I cannot tolerate certain pain medications given through the spine.

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I have had a heart attack or abnormal heart stress test in the last 3 months.

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My kidney function is impaired with creatinine over 2.0 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Natural Killer Cell Cytotoxicty

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 'Bupivacaine + Fentanyl' (Opioid Group)Experimental Treatment1 Intervention

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 II: Bupivacaine (Local Anesthetic Group)Active Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine + Fentanyl

2022

N/A

~40

0 / 18Eligibility criteria met