Bupivacaine for Post-operative Pain After Breast Cancer Surgery

Recruiting at 9 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

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding the numbing medicine bupivacaine to the usual pain medications after breast cancer surgery can better control pain and reduce the need for opioids. It compares the effects of bupivacaine with a simple saline solution (saltwater) as part of post-surgery care. The study seeks participants undergoing a single breast removal surgery without immediate reconstruction or additional procedures. Those with frequent pain unrelated to the breast, who take long-acting pain medication, or who plan to have both breasts removed at once may not be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

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.

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

Research has shown that bupivacaine, a numbing medicine, is generally safe when used correctly. It often helps manage pain after surgery. One study found that bupivacaine effectively reduces post-surgery pain without major safety concerns. However, large amounts can cause problems throughout the body, not just in the treated area.

Another study found that bupivacaine provides excellent pain relief and may reduce the need for opioid painkillers, which can have their own side effects. This suggests that bupivacaine can manage pain effectively with fewer side effects. Overall, evidence supports that bupivacaine is well-tolerated in humans for managing post-surgery pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for post-operative pain management after breast cancer surgery, which typically involves oral pain medications like opioids and NSAIDs, bupivacaine offers a localized solution. Bupivacaine is administered directly into the mastectomy wound, potentially providing targeted pain relief right where it's needed. This local delivery method could minimize the need for systemic pain relievers and their associated side effects, such as nausea and drowsiness. Researchers are excited about bupivacaine because it may offer more effective pain control with fewer systemic side effects, leading to a smoother recovery process.

What evidence suggests that bupivacaine might be an effective treatment for post-operative pain after breast cancer surgery?

Research has shown that bupivacaine reduces pain after surgery. Studies have found that it provides long-lasting pain relief and decreases the need for opioid painkillers. Specifically, using bupivacaine in breast surgery significantly lowers pain levels. It is well-regarded for having few side effects, making it a reliable choice for pain management. Additionally, bupivacaine works effectively in nerve blocks, offering strong pain control. In this trial, one group of participants will receive bupivacaine alongside standard post-surgery medications, which could be beneficial based on these findings. ^{1 4 6 7 8}

Who Is on the Research Team?

Laurie Kirstein, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3539479/

A randomized, double-blind, placebo-controlled trial of ... The beneficial effect of bupivacaine on the level of pain reported by patients in the post-operative period contributed to eventual inclusion of this method in ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/10/e108951.full.pdf

Comparing the analgesic efficacy of liposomal bupivacaine ... Outcome measures: The primary outcome will be post- operative pain intensity within 72 hours after surgery, assessed using validated scales such ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03393117

Study Details | NCT03393117 | Bupivacaine Versus ... This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3327067/

Post-operative pain and analgesic requirements after ... Paravertebral block (PVB) is useful for post-operative analgesia after breast surgery. Bupivacaine is used for PVB at higher concentrations (0.5%), ...

5. withpower.com withpower.com/trial/phase-3-10-2017-532d7

Bupivacaine for Post-operative Pain After Breast Cancer ... It is known for its long-lasting pain relief and minimal side effects, making it a reliable choice for managing post-surgery discomfort.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496121/

Effect of liposomal bupivacaine combined with ... Ultrasound-guided nerve blockages boast advantages such as excellent analgesic effects, reduced dosage of opioid drugs, fewer adverse reactions ...

7. journals.viamedica.pl journals.viamedica.pl/rpor/article/view/105039

Liposomal bupivacaine and postoperative opioid ... The purpose of this review is to evaluate postoperative opioid consumption when using LB in aesthetic breast surgery vs oncologic breast surgery ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04362566?tab=table

NCT04362566 | Bupivacaine for Post-operative Pain in Mohs A newer formulation of liposomal bupivacaine has been shown to be even longer lasting and safer, with pain control up to 72 hours and no reported cardiac ...