Pain Management After Breast Reduction
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?
How is the drug Liposomal Bupivacaine unique for pain management after breast reduction?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Liposomal Bupivacaine or 0.25% Bupivacaine Hydrochloride during breast reduction surgery
Follow-up
Participants are monitored for pain scores and opioid use for 72 hours post-operatively
Extended Follow-up
Participants may be monitored for any long-term effects or complications
Treatment Details
Interventions
- Bupivacaine Hydrochloride
- Liposomal Bupivacaine
Liposomal Bupivacaine is already approved in United States for the following indications:
- 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