The Use Of Liposomal Bupivacaine For Pain Control

• Status: Completed
• Trial end date: 2020-01-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Bupivacaine

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