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The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.
This is a prospective, multi-surgeon, single blind, non-randomized, controlled trial with breasts allocated to two parallel groups: A mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride will be used on one side (Treatment side) as local infiltration, and plain 0.25% Bupivacaine Hydrochloride will be used in the control arm. Each breast will serve as the control for the other. The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively. These treatments are standard of care in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Breast Treatment Group: Bupivacaine Hydrochloride | Active Comparator | Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast. |
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| Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine | Experimental | Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | 20 ml of 0.25% Bupivacaine (50 mg) with 20 ml of injectable saline (total of 40 cc) as a subcutaneous infiltration along the inframammary fold incision on one breast |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores in the first 72 hours post-operatively following breast reduction | Measured using validated self-reported Numerical Pain Rating Scale (NPRS). Participants rate pain using a scale of 0=none and 10=most severe. | 72 hours post-operatively |
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Inclusion Criteria
- Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Basel Sharaf, MD, DDS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Liposomal Bupivacaine | Drug | 20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast |
|
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| D000588 |
| Amines |