Bupivacaine for Post-operative Pain After Breast Cancer Surgery

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Laurie Kirstein, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Long acting opioids

Disqualifiers: Non-English speaking, Bilateral mastectomy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

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}

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.

Trial 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 (Local Anesthetic)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Monmouth (Consent and follow-up only) Middletown, NJ

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) Basking Ridge, NJ

Memorial Sloan Kettering Commack (Consent and follow-up only) Commack, NY

Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

References

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

[The use of Marcaine in obstetrical analgesia]. [2013] Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.

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

Bupivacaine: a review. [2018] A review of current significant literature concerning bupivacaine hydrochloride (Marcaine) is presented with particular emphasis on clinical use in oral surgery. The major advantages compared with other presently used local anesthetics are an increased duration of action and a favorable potency to toxicity ratio.

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

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021] Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication.

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] Bupivacaine (Marcaine), homologue of mepivacaine, chemically related to lidocaine, is used as a local anesthetic for local infiltration, peripheral nerve block, retrobulbar block, symphathetic block, and caudal and epidural anesthesia. The aim of this investigation was to determine and to compare clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor.

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

The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? [2018] A simple technique of wound perfusion with bupivacaine (Marcain) which provides sustained postoperative analgesia is described. No complications nor side effects related to toxicity, hypersensitivity, infection, or impaired wound healing were encountered. Postoperative pain was reduced and analgesic requirements were significantly lower in patients undergoing both intermittent (P less than 0.01) and continuous (P = 0.1) wound perfusion (Student t test). Perfusion with isotonic saline was also found to be effective. This may represent a true therapeutic effect attributable to the removal or dilution of pain mediating substances in the wound.

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

Postoperative pain relief using local anesthetic instillation. [2019] Effective pain control following surgery is a concern. Oral narcotic agents may be effective yet have many side effects. Parenteral agents are impractical in outpatient procedures. Local blocks may distort tissue planes and require additional time and technical skill to administer. We have found that instillation of local anesthetic (0.5% bupivacaine [Marcaine, Sensorcaine]) into the wound prior to closure is a safe and effective means of providing significant reduction in postoperative foot pain.

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] The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting.

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] Two forms of 0.5% bupivacaine hydrochloride, Anecaine (Pliva) (n = 15) and Marcaine (Astra) (n = 15) were used for epidural anesthesia. The clinical picture of conduction block induced by the two local anesthetics varied. It manifested by a shorter latent period of analgesia development at the level of catheter and the drug infusion (LII) and relatively delayed development of analgesia in peripheral zones for Anecaine in comparison with marcaine. The authors conclude that solutions of local anesthetics containing the same active agent in the same concentrations under different commercial names manufactured by different companies may be characterized by different clinical picture of conduction blockade.

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

[Ropivacaine infiltration during breast cancer surgery: postoperative acute and chronic pain effect]. [2022] Decrease acute pain after breast cancer surgery by an infiltration of ropivacaine. Analyse effect on chronic pain.