Bupivacaine for Post-operative Pain After Breast Cancer Surgery

Recruiting at 8 trial locations

Overseen By Laurie Kirstein, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Long acting opioids

Disqualifiers: Non-English speaking, Bilateral mastectomy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 hours ± 30 minutes

144 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that patients taking long-acting opioid medications are excluded. It seems you can continue with usual pain medications, but check with the trial team for specifics.

What data supports the effectiveness of the drug Bupivacaine for post-operative pain after breast cancer surgery?

Research shows that Bupivacaine, also known as Marcaine or Sensorcaine, is effective in reducing post-operative pain in breast reduction surgeries and other procedures, with patients experiencing less pain and needing fewer pain medications. It is known for its long-lasting pain relief and minimal side effects, making it a reliable choice for managing post-surgery discomfort. ^{1 2 3 4 5}

Is bupivacaine safe for use in humans?

Bupivacaine, also known as Marcaine or Sensorcaine, is generally considered safe for use in humans when used as directed. It has been used effectively for pain management in various surgeries, including breast and foot surgeries, with minimal side effects when proper dosing guidelines are followed. ^{1 3 4 6 7}

How does the drug bupivacaine differ from other treatments for post-operative pain after breast cancer surgery?

Bupivacaine is a long-acting local anesthetic that can be applied topically during surgery to manage post-operative pain, potentially reducing the need for narcotic pain medications. Its unique feature is its prolonged pain relief, which is particularly beneficial in the first 48 hours after surgery, a period when patients often experience the most discomfort. ^{1 3 4 8 9}

Research Team

Laurie Kirstein, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women over 18 years old undergoing a unilateral mastectomy, with or without lymph node removal. It's open to those having surgery at specific centers and who haven't had the opposite breast removed within the last 6 months. Excluded are men, bilateral mastectomy patients, long-term opioid users, those under 40kg, non-English speakers, immediate reconstruction cases, and anyone with significant baseline pain.

Inclusion Criteria

It's been over 6 months since my other breast was removed.

I am scheduled for surgery at JRSC or MSK Monmouth.

I am having or had a mastectomy on one breast, with or without lymph node removal.

Exclusion Criteria

I am having both of my breasts removed.

I am a male diagnosed with breast cancer.

I experience pain greater than 3 not related to breast surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bupivacaine or saline via a drain into the mastectomy wound for 2 hours postoperatively

2 hours ± 30 minutes

Follow-up

Participants are monitored for pain levels and nausea using validated scales

24 hours

Treatment Details

Interventions

• Bupivacaine

Trial Overview The study tests if adding bupivacaine—a numbing medication—directly to the surgical site can better manage post-surgery pain compared to usual painkillers alone. The goal is also to see if this method reduces opioid use after surgery. Participants will either receive bupivacaine or saline (placebo) alongside standard care.

Participant Groups

Group I: Bupivacaine + usual post-operative medications Experimental Treatment 2 Interventions

The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Group II: Saline + usual post-operative medications Active Control 2 Interventions

The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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 hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

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 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]

Wound perfusion with bupivacaine provides effective and sustained postoperative pain relief without any complications or side effects, indicating its safety for use in patients.

Both intermittent and continuous wound perfusion significantly reduced postoperative pain and analgesic requirements, suggesting that this technique can enhance recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? Thomas, DF., Lambert, WG., Williams, KL.[2018]

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

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 involving 81 patients, infiltration of ropivacaine did not significantly reduce acute pain after breast cancer surgery compared to a placebo, as measured by pain scores and medication use.

One year later, there was no difference in the incidence of chronic pain between the ropivacaine and placebo groups, indicating that ropivacaine scar infiltration was ineffective for both acute and chronic pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ropivacaine infiltration during breast cancer surgery: postoperative acute and chronic pain effect]. Baudry, G., Steghens, A., Laplaza, D., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

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

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

Bupivacaine: a review. [2018]

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

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? [2018]

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

Postoperative pain relief using local anesthetic instillation. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

8. 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]

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

[Ropivacaine infiltration during breast cancer surgery: postoperative acute and chronic pain effect]. [2022]