Pain Management After Breast Reduction

Overseen By BMSO Research Team

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids, Antiplatelets, Anticoagulants

Disqualifiers: Chronic pain, Pregnancy, Liver dysfunction, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two pain treatments after breast reduction surgery. It compares a standard treatment, Bupivacaine Hydrochloride, with a newer version, Liposomal Bupivacaine (Exparel). The goal is to determine which treatment better manages pain and reduces the need for opioid medications. Women with large, painful breasts planning to undergo breast reduction surgery may be suitable candidates for this study. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, aiming to understand how they benefit 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 you cannot participate if you use antiplatelet or anticoagulation therapy.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine is generally safe for use in surgeries. Studies have found it can reduce the need for opioids after surgery, effectively managing pain. Patients using liposomal bupivacaine reported fewer side effects compared to traditional pain treatments.

One study found that liposomal bupivacaine lowered pain levels and shortened hospital stays for patients undergoing breast reconstruction, suggesting it provides effective pain relief and is well-tolerated.

While bupivacaine hydrochloride is a common pain management option, liposomal bupivacaine lasts longer, potentially offering extended pain relief with fewer doses.

Overall, evidence supports the safety of liposomal bupivacaine in managing post-surgery pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about liposomal bupivacaine for pain management after breast reduction surgery because it offers a unique way to manage pain. Unlike standard bupivacaine hydrochloride, which provides pain relief for a few hours, liposomal bupivacaine releases the medication slowly over time, potentially offering longer-lasting pain control. This extended-release formulation can mean fewer doses are needed, possibly reducing the reliance on opioids and improving recovery comfort. This innovative approach has the potential to enhance post-surgical care significantly.

What evidence suggests that this trial's treatments could be effective for pain management after breast reduction?

This trial will compare two pain management treatments for patients undergoing breast reduction surgery. Research has shown that liposomal bupivacaine (Exparel), administered to participants in one arm of this trial, helps manage post-surgery pain. Specifically, studies found that patients receiving this treatment reported significantly lower pain levels than those receiving standard treatments. They also required fewer opioid painkillers, reducing the risk of side effects from these medications. Clinical evidence confirms its safety and effectiveness, particularly for reducing pain after breast surgeries. This treatment has already proven effective in managing post-surgery pain. ^{2 3 4 6 7}

Who Is on the Research Team?

Basel Sharaf, MD, DDS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adult women aged 18-70 with symptomatic macromastia who are scheduled for breast reduction surgery using a specific incision technique. It's not specified who can't join, but typically those with health conditions affecting the study outcome would be excluded.

Inclusion Criteria

I am a woman aged 18-70 with large breasts causing symptoms, planning a specific breast reduction surgery.

Exclusion Criteria

I need daily pain medication for chronic pain.

I have had radiation therapy to my chest before.

I cannot have breast reduction due to my medical or surgical history.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Liposomal Bupivacaine or 0.25% Bupivacaine Hydrochloride during breast reduction surgery

Immediate post-operative period

1 visit (in-person, surgery day)

Follow-up

Participants are monitored for pain scores and opioid use for 72 hours post-operatively

72 hours

Daily monitoring (virtual or in-person)

Extended Follow-up

Participants may be monitored for any long-term effects or complications

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Hydrochloride
• Liposomal Bupivacaine

Trial Overview The study compares pain control and opioid use after breast reduction surgery between two drugs: Liposomal Bupivacaine (Exparel) and standard Bupivacaine Hydrochloride. Participants will receive one of these medications to manage post-surgery pain.

How Is the Trial Designed?

Group I: Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine Experimental Treatment 2 Interventions

Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.

Group II: Control Breast Treatment Group: Bupivacaine Hydrochloride Active Control 1 Intervention

Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.

Liposomal Bupivacaine is already approved in United States for the following indications:

Approved in United States as EXPAREL for:

• Postsurgical local analgesia via infiltration in adults
• Regional analgesia via interscalene brachial plexus nerve block in adults

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 44 patients undergoing breast reconstruction, liposomal bupivacaine did not show any significant advantages over conventional bupivacaine in terms of pain relief, opioid consumption, or recovery outcomes.

Both types of bupivacaine provided similar results in a postoperative setting, suggesting that the longer-lasting effects of liposomal bupivacaine may not be beneficial when combined with an enhanced recovery protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial. Ha, AY., Keane, G., Parikh, R., et al.[2021]

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]

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]

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]

A review of 76 randomized controlled trials found that only 11% showed a significant benefit of liposomal bupivacaine over standard bupivacaine or ropivacaine for postoperative pain control.

The majority of trials indicated that unencapsulated bupivacaine provided better pain relief than liposomal bupivacaine, suggesting that routine use of liposomal bupivacaine may not be justified based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Ilfeld, BM., Eisenach, JC., Gabriel, RA.[2021]

In a study of 50 patients undergoing vaginal reconstructive surgery, liposomal bupivacaine (LB) did not show any significant advantage over plain bupivacaine in terms of postoperative pain control, narcotic use, or length of hospital stay.

Despite LB's higher cost, the results indicate that it is not more effective than plain bupivacaine for managing pain after surgery, suggesting a need for further research to find the best pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. Jensen, S., Amasyali, AS., Keheila, M., et al.[2023]

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]

A 45-year-old woman with severe digital ischemic pain showed marked improvement after receiving an axillary nerve block with liposomal bupivacaine (Exparel), suggesting its potential role in managing vasoocclusive symptoms despite being used off-label.

This case highlights the analgesic properties of liposomal bupivacaine in a patient who was not a candidate for surgical interventions, indicating that it may provide significant pain relief in similar cases of ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of digital ischemia with liposomal bupivacaine. Soberón, JR., Duncan, SF., Sternbergh, WC.[2021]

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12570905/

Comparing the analgesic efficacy of liposomal bupivacaine ... For example, a trial by Nadeau et al reported significantly lower pain scores in the liposomal bupivacaine group compared with the standard ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4457254/

Postoperative Pain and Length of Stay Lowered by Use of ... This study supports the use of LB for postoperative pain management in immediate, implant-based breast reconstruction patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824001967

Efficacy of pectoralis nerve blocks I & II with liposomal ... This retrospective study showed that the use of PECs blocks with plain local anesthetic and LB resulted in significantly lower outpatient opioid consumption ...

4. academic.oup.com academic.oup.com/bjs/article/111/Supplement_6/znae163.524/7743865

751 Efficacy of Liposomal Bupivacaine (Exparel) for Post ... Liposomal bupivacaine was shown to be safe and led to a reduction in post-operative opioid requirements compared to controls.

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

Liposomal bupivacaine and postoperative opioid ... Some studies have demonstrated promising results related to the efficacy of liposomal bupivacaine (LB), a long-acting local analgesic used ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5732669/

Liposomal Bupivacaine in Implant-Based Breast ... This study evaluates the role of liposomal bupivacaine in implant-based breast reconstruction. A prospective, randomized, single-blind trial of liposomal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ... These findings suggest that LB may be a safe and promising agent for prolonging postoperative analgesia and minimizing donor site pain. Some studies have ...