Comparing two types of bupivacaine for pain control after breast reduction surgery
Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride for Postoperative Analgesia After Breast Reduction Surgery: a Prospective, Single Blind, Non-randomized Controlled Trial
This study is testing whether a special form of bupivacaine can help reduce pain better than the regular version after breast reduction surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05891613 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of liposomal bupivacaine versus standard bupivacaine hydrochloride in managing postoperative pain in patients undergoing breast reduction surgery. It is a prospective, multi-surgeon, single-blind, non-randomized, controlled trial where each breast serves as its own control. The study aims to assess pain scores and opioid consumption for up to 72 hours post-surgery, providing insights into the efficacy of these pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are adult female patients aged 18-70 with symptomatic macromastia scheduled for breast reduction surgery.
Not a fit: Patients with significant chronic pain, previous breast surgeries, or contraindications to bupivacaine will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced opioid use for patients undergoing breast reduction surgery.
How similar studies have performed: Other studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design. Exclusion Criteria * Inability to provide informed consent * Medical or surgical history precluding breast reduction * History of significant chronic pain requiring daily use of opioid or nonopioid analgesics * Pregnancy * Concomitant non-breast surgical procedure * Previous chest wall irradiation * Previous breast implant, breast reduction or breast lift surgery * Known allergy to bupivacaine or liposomal bupivacaine * Liver or kidney dysfunction * Use of antiplatelet or anticoagulation therapy.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Basel Sharaf, MD, DDS — Mayo Clinic
- Study coordinator: BMSO Research Team
- Email: BMSORESEARCH@mayo.edu
- Phone: 507-538-4849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.