42 Participants Needed

Pain Management After Breast Reduction

BR
Overseen ByBMSO Research Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.13567

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.13589

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

BS

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.
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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
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Breast Treatment Group: Liposomal (Exparel) BupivacaineExperimental Treatment2 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 HydrochlorideActive Control1 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

Find a Clinic Near You

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.
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.
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.
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]

References

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]
Liposomal Bupivacaine May Benefit Select Reduction Mammaplasty Patients. [2019]
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]
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]
Treatment of digital ischemia with liposomal bupivacaine. [2021]
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