Anesthetic Techniques for Pain and Anesthesia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Antiarrhythmics, Antidepressants, Antipsychotics, others

Disqualifiers: Coronary artery disease, Hypertension, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different pain management techniques affect the body's natural killer cells, crucial for fighting infections and cancer. Participants will receive either a combination of bupivacaine and fentanyl (a pain reliever) or just bupivacaine during and after abdominal surgery. The trial aims to determine which method might better support the immune system. It seeks individuals scheduled for abdominal tumor surgery who can receive epidural pain relief. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance post-surgical care and immune support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking certain drugs that cause prolonged QT intervals or are on chronic opioids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using bupivacaine and fentanyl together is generally safe and effective for pain relief. Studies examining this combination for managing pain during and after surgery have found that it reduces pain and lessens the need for additional strong painkillers.

This combination is considered safe when used in the epidural space, the area around the spinal cord where pain relief medications are often administered. Some individuals might experience mild side effects like itching, but serious side effects are rare.

Both bupivacaine and fentanyl are commonly used in medical settings and have well-known safety records, making them a reliable choice for pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these anesthetic techniques because they offer potential improvements in managing pain during and after surgery. The use of bupivacaine combined with fentanyl in the opioid group provides a potent mix of a local anesthetic and an opioid, which could enhance pain relief and anesthesia effectiveness compared to standard options that often use these drugs separately. Additionally, the ability to titrate the combination specifically to surgical and post-operative needs offers more personalized pain control. In contrast, the local anesthetic group focuses on using bupivacaine alone, which may reduce opioid-related side effects while still providing effective anesthesia, appealing to those seeking alternatives to opioid use.

What evidence suggests that this trial's anesthetic techniques could be effective for pain and anesthesia?

In this trial, participants will join different treatment groups to evaluate pain relief methods. Research has shown that combining bupivacaine and fentanyl, as in the opioid group of this trial, effectively relieves pain. Studies have found that this combination can significantly reduce post-surgical pain and decrease the need for additional pain medication. Patients who received both drugs reported less pain and greater comfort after surgery. Meanwhile, bupivacaine alone, used in the local anesthetic group, effectively numbs nerves to block pain signals, aiding in pain management during and after surgery. Both treatments offer promising options for controlling surgical pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Roya Yumul, MD, PhD

Principal Investigator

Program Director, Department of Anesthesiology

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive general endotracheal anesthesia with an epidural containing either fentanyl + bupivacaine or bupivacaine alone during exploratory abdominal laparotomies

1 week

Follow-up

Participants are monitored for natural killer cell cytotoxicity using flow cytometric analysis

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Fentanyl

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 435 patients, bupivacaine (0.75% in 8.25% dextrose) demonstrated superior efficacy compared to tetracaine for spinal anesthesia, with only one unsatisfactory anesthesia case in the bupivacaine group versus 19 in the tetracaine group for the lower dose.

Bupivacaine was found to be a safe and reliable option for spinal anesthesia, although tetracaine provided longer motor blockade; adding epinephrine to either anesthetic significantly extended their duration of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. Moore, DC.[2013]

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