Pain Relief Methods for Breast Cancer Surgery

Overseen By Grant A Miller, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: United States Naval Medical Center, Portsmouth

Must not be taking: Antithrombotics

Disqualifiers: Allergy, Infection, Neural deficits, Coagulopathy, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate pre-surgery

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two pain relief methods—dexmedetomidine (a sedative and pain relief medication) and liposomal bupivacaine (a long-acting local anesthetic)—work when added to bupivacaine for managing pain after breast cancer surgery, specifically mastectomy. The goal is to determine which option provides longer-lasting relief and reduces the need for additional opioid pain medications. It suits individuals planning a mastectomy who are open to receiving a nerve block (a numbing procedure) for post-surgery pain management. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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 mentions that patients taking antithrombotic drugs outside certain guidelines are excluded. It's best to discuss your current medications with the trial team.

What is the safety track record for dexmedetomidine and liposomal bupivacaine?

Research has shown that both dexmedetomidine and liposomal bupivacaine are safe and effective for managing pain.

Dexmedetomidine effectively manages post-surgical pain, helps control vital signs, and can reduce the need for additional pain medication. Some studies suggest it may aid in both immediate and long-term pain relief after breast cancer surgery. However, its impact on cancer progression remains uncertain, with studies showing mixed results.

Liposomal bupivacaine is well-tolerated. Research indicates it can lower pain levels after surgery and reduce the need for opioids. In some cases, patients experienced less pain for up to 72 hours post-surgery. Importantly, no side effects were noted, suggesting it is safe to use.

Both treatments have shown promise in managing post-surgical pain with minimal side effects, making them potentially safe options for patients considering joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for pain relief in breast cancer surgery because they offer innovative approaches to managing post-surgical discomfort. Unlike the standard of care, which typically involves systemic opioids, these treatments use targeted nerve blocks. One arm uses dexmedetomidine, a sedative that enhances pain relief when combined with bupivacaine, providing potentially longer-lasting and more effective analgesia. The other arm utilizes liposomal bupivacaine, which slowly releases the anesthetic over time, potentially extending pain relief and reducing the need for additional medication. These methods aim to improve patient comfort and minimize opioid dependency after surgery.

What evidence suggests that this trial's treatments could be effective for pain relief after breast cancer surgery?

In this trial, participants will receive one of two pain relief methods after breast cancer surgery. Research has shown that dexmedetomidine, included in one treatment arm, effectively reduces pain post-surgery. Studies have found that it lowers pain scores and reduces the need for morphine, a common painkiller, within the first 24 hours after surgery. This suggests dexmedetomidine might aid in pain relief after breast cancer surgery.

For the other treatment arm, liposomal bupivacaine is used. Studies indicate that liposomal bupivacaine can lower pain levels and reduce the need for opioids after procedures. It has been found to provide significant pain relief for up to 72 hours after surgery, potentially managing post-surgery pain effectively and reducing hospital stays.

Both treatments have shown promise in managing pain after surgery, making them good options for those undergoing breast cancer surgery. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients undergoing any type of mastectomy, with or without axillary lymph node dissection. Participants must consent to a peripheral nerve block and agree to be part of the study. The anesthesia team must approve the block based on medical history, and the surgeon must agree with the plan.

Inclusion Criteria

I agree to participate in the study.

I need a mastectomy, possibly with lymph node removal.

I agree to have a peripheral nerve block.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an erector spinae plane block with either liposomal bupivacaine or bupivacaine with dexmedetomidine for postoperative pain control during mastectomy surgery

Immediate pre-surgery

1 visit (in-person)

Postoperative Monitoring

Participants' pain scores and morphine equivalence are monitored every 6 hours while inpatient, and pain scores are collected up to 72 hours post-discharge

96 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Liposomal Bupivacaine

Trial Overview The study compares two pain relief methods in post-mastectomy care: liposomal bupivacaine versus bupivacaine mixed with dexmedetomidine in an erector spinae plane block. It aims to determine which combination provides longer-lasting pain control and reduces opioid use while hospitalized.

How Is the Trial Designed?

Group I: Bupivacaine plain with dexmedetomidine Experimental Treatment 1 Intervention

Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 0.25% bupivacaine plain 30 ml plus dexmedetomidine 0.5 mcg/kg per side of the block.

Group II: Liposomal bupivacaine and bupivacaine plain erector spinae plane block Active Control 1 Intervention

Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 1.33% liposomal bupivacaine 10ml plus 0.25% bupivacaine plain 20 ml per side of the block.

Who Is Running the Clinical Trial?

United States Naval Medical Center, Portsmouth

Lead Sponsor

Trials

35

Recruited

4,900+

Published Research Related to This Trial

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

Liposomal bupivacaine significantly reduced postoperative pain and the need for antiemetics in certain obesity classes, particularly showing lower pain scores immediately after surgery and at discharge for obesity class I patients.

Patients receiving liposomal bupivacaine had shorter hospital stays, especially among premenopausal women, indicating potential benefits in recovery time and overall patient outcomes compared to standard bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. Kalaria, SS., Boukovalas, S., Padilla, PL., et al.[2019]

In a study of 90 patients undergoing immediate breast reconstruction, the use of liposomal bupivacaine (LB) significantly reduced postoperative pain scores compared to traditional pain management methods, indicating its efficacy as a pain reliever.

Patients receiving LB also had a shorter hospital stay (1.5 days) compared to those on narcotics (2.0 days), with no reported adverse events, highlighting its safety and potential benefits in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Butz, DR., Shenaq, DS., Rundell, VL., et al.[2022]

The case study discusses a 35-year-old woman undergoing surgery for a painful breast tumor and highlights strategies to minimize the risk of developing chronic pain after the operation.

Various methods such as preoperative medications, nerve blocks, local anesthetics, and postoperative epidural pharmacotherapy are suggested to effectively manage pain and reduce the likelihood of chronic pain post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management discussion forum: prevention of chronic postoperative pain. Breivik, H.[2014]

In a study of 45 female patients undergoing major breast cancer surgery, the addition of dexmedetomidine to bupivacaine in paravertebral blocks significantly reduced postoperative pain and opioid consumption, leading to better overall patient satisfaction.

Patients receiving the dexmedetomidine combination experienced lower pain scores and a reduced incidence of nausea and vomiting, while maintaining similar rates of hypotension and bradycardia compared to other groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine as an adjuvant in paravertebral block in breast cancer surgery. Mohta, M., Kalra, B., Sethi, AK., et al.[2022]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

In a study of 86 breast cancer surgery patients, perioperative administration of dexmedetomidine significantly reduced the incidence and severity of chronic pain compared to a saline control, as measured by standardized pain questionnaires three months post-surgery.

Patients receiving dexmedetomidine also reported better quality of life scores, indicating that this medication not only helps manage pain but also enhances overall well-being after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the perioperative infusion of dexmedetomidine on chronic pain after breast surgery. Jain, G., Bansal, P., Ahmad, B., et al.[2022]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5422527/

Dexmedetomidine Improves Postoperative Patient ... During the first 24 h following surgery, patients receiving dexmedetomine had lower NRS pain scores, decreased morphine consumption, longer time to first ...

2. e-century.us e-century.us/files/ajtr/16/12/ajtr0159193.pdf

Clinical efficacy of dexmedetomidine preemptive analgesia ... Zusman et al. reported that dexmedetomidine effectively enhances peripheral nerve block- ade, prolonging postoperative pain relief, reducing ...

3. brieflands.com brieflands.com/journals/semj/articles/118622

The Effect of Intraoperative Infusion of Dexmedetomidine ... on 84 patients with breast cancer showed that dexmedetomidine infusion before surgery significantly reduced the acute postoperative pain and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225002053

Effect of intraoperative dexmedetomidine on prognosis in ... The impact of dexmedetomidine on outcomes after cancer surgery is controversial, with evidence for both positive and negative effects on cancer progression.

5. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2025.2551279

Full article: Regarding effect of different doses ... In these cases, it is a dilemma for the readers to determine whether decreased postoperative pain intensity and improved postoperative recovery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240532/

A randomized controlled clinical trial to investigate the efficacy ... Conclusions: Dexmedetomidine could effectively manage the vital signs of patients with postoperative acute pain, improve treatment outcomes, ...