The Use Of Liposomal Bupivacaine For Pain Control

Phase 4

Completed

Brief 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.

Detailed Description: Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine Group	Liposomal Bupivacaine	Participants will be randomized to the Liposomal Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction
Bupivacaine Group	Bupivacaine	Participants will be randomized to the Bupivacaine Group and receive a bilateral mastectomy with immediate implant based breast reconstruction

Primary Outcome Measures

Name	Time	Method
Mean Visual Analog Scores	48 hours	This will be measured every 12 hours for the first 48 hours postoperatively by the level of breast pain associated with arm movements while eating on a scale of 0-10 with higher scores denoting worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve Visual Analog Scores (Submuscular Augmentation Mammoplasty)	48 hours	This will be measured during first 48 hours postoperatively
Length of Stay for Hospitalization	up to 47 Hours	The length of stay for hospitalization after mastectomy and breast reconstruction will be recorded.
Number of Morphine Doses Across All Subjects	1 Month	This will be measured by the number of doses within the first month postoperatively and recorded on pain medication daily diary kept by subject.
Readmission Rates to the Hospital	Month 2	Readmission rates to the hospital within 2 months after mastectomy and breast reconstruction will be recorded
Frequency of Postoperative Opioid Related Adverse Effects	Postoperatively, 1 week	Frequency of postoperative opioid related adverse effects within the first week of surgery will be recorded. This includes nausea, vomiting, pruritus, allergy, respiratory depression.
Pain Intensity With Movement	Up to 2 months	This will be measured by using the Pain Assessment Questionnaire. Total scores are 0-50 with higher scores denoting worse outcomes.