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

42 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug for pain management after breast reduction surgery?

Liposomal bupivacaine, a form of bupivacaine that releases the drug slowly over time, has been shown to be a safe and effective pain reliever in breast reconstruction surgeries, potentially reducing the need for opioids and shortening hospital stays. However, the overall evidence is mixed, with some studies suggesting it may not be more effective than standard local anesthetics. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for pain management after surgery?

Liposomal bupivacaine (EXPAREL) has been shown to be safe for managing pain after various surgeries, including breast augmentation and reconstruction, and has been used safely in both adults and children. ^{1 3 5 6 7}

How is the drug Liposomal Bupivacaine unique for pain management after breast reduction?

Liposomal Bupivacaine (Exparel) is unique because it provides long-lasting pain relief for up to 72 hours, reducing the need for opioids and potentially shortening hospital stays compared to standard local anesthetics. ^{1 3 5 8 9}

What is the purpose of this trial?

The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

Research Team

Basel Sharaf, MD, DDS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

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]

References

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

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]

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

Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Canada pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]

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

Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

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

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]

8. United States 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. [2021]

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

Treatment of digital ischemia with liposomal bupivacaine. [2021]