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

20 Participants Needed

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.

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.

What data supports the effectiveness of the drug Bupivacaine, Marcaine, Sensorcaine, Fentanyl, Sublimaze, Actiq, Duragesic, Fentora, Abstral, Onsolis for pain and anesthesia?

Research shows that bupivacaine, a component of the drug, is effective in managing postoperative pain, especially when used with fentanyl, as it extends the duration of pain relief. Additionally, Sensorcaine (a form of bupivacaine) has been found to improve pain management after certain surgeries. ^{1 2 3 4 5}

Is bupivacaine generally safe for use in humans?

Bupivacaine, used in various forms for anesthesia, has been shown to be generally safe in humans, with studies involving thousands of cases reporting only a few systemic toxic reactions and no serious long-term effects. Levobupivacaine, a related anesthetic, has lower risks of heart and nerve side effects compared to traditional bupivacaine, making it suitable for high-risk patients. ^{1 2 6 7 8}

How does the drug bupivacaine with fentanyl differ from other pain management options?

The combination of bupivacaine and fentanyl for spinal anesthesia offers a reliable and safe option with a predictable duration of action, making it suitable for day-case surgeries like inguinal herniorrhaphy. This mixture provides effective pain relief with potentially fewer side effects compared to other local anesthetics, and the addition of fentanyl can enhance the analgesic effect. ^{1 6 9 10 11}

Research Team

Roya Yumul, MD, PhD

Principal Investigator

Program Director, Department of Anesthesiology

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 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

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

Treatment Details

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.

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Liposomal Bupivacaine for Opioid and Pain Reduction: A Systematic Review of Randomized Clinical Trials. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Wound infiltration with plain bupivacaine as compared with bupivacaine fentanyl mixture for postoperative pain relief after abdominal surgery. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Comparison of bupivacaine and fentanyl as an adjuvant of epidural morphine for postoperative analgesia. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. [2019]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

[Chirocaine in ophthalmology]. [2013]

9. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

10. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Randomised comparison of hyperbaric articaine and hyperbaric low-dose bupivacaine along with fentanyl in spinal anaesthesia for day-case inguinal herniorrhaphy. [2013]