The Use Of Liposomal Bupivacaine For Pain Control
Condition: Pain, Breast
MeSH terms: Mastodynia
Intervention: Bupivacaine; Liposomal Bupivacaine
Intervention description: While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.; While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Women of all races and ethnicity who meet the above-described eligibility criteria are eligible to participate in this study. Approximately 5% of study participants to be Hispanic/Latino (N=5), 10% Black or African American (N=10), 1% American Indian/Alaska Native (N=1), and 5% Asian (N=5).
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bupivacaine; Liposomal Bupivacaine; Mastectomy; Breast Reconstruction; Pain Control

Summary:

      The purpose of this research study is to determine how well the local anesthetic, liposomal
      bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who receive a bilateral mastectomy with immediate sub-pectoral implant
             based breast reconstruction

          -  Age ≥ 18 years

          -  Ability to understand and the willingness to sign an (Institutional Review Board)
             IRB-approved informed consent document.

          -  Patients who receive tissue expander placement or direct permanent implant placement
             will be included in the study.

        Exclusion Criteria:

          -  Patients who receive an autologous tissue reconstruction.

          -  Patients who receive a unilateral reconstruction.

          -  Patients who are expected to undergo axillary lymph node dissection

          -  Patients who have undergone breast irradiation

          -  Patients who abuse narcotics or have chronic pain (using greater than 40 mg
             equivalents of oxycodone per day)

          -  Patients who are wards of the state

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to bupivacaine or liposomal bupivacaine.

          -  Pregnant women are excluded from this study because pregnancy precluded immediate
             breast reconstruction in our patient population.

          -  Patients who weigh less than 50 kg, as there can be dose related toxicities of the
             bupivacaine dosing used n this study.

          -  Patients with moderate-severe hepatic or renal impairment because of the increased
             risk of toxicity.

          -  Patients receiving bilateral mastectomy with immediate pre-pectoral implant based
             reconstruction