Anesthetic Techniques for Pain and Anesthesia

Recruiting in Palo Alto (17 mi)

Overseen by Roya Yumul, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I can have an epidural.

I am between 18 and 80 years old.

I am scheduled for surgery to explore my abdominal tumor.

Exclusion Criteria

Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis

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

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

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• Fentanyl (Opioid Analgesic)

Trial Overview 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.

Participant Groups

Group I: 'Bupivacaine + Fentanyl' (Opioid Group) Experimental Treatment 1 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 Control 1 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.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

🇪🇺 Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

🇨🇦 Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cedars Sinai Medical Center Los Angeles, CA

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center Lead Sponsor

References