This phase IV trial studies how well liposomal bupivacaine works compared to bupivacaine for pain control following mastectomy and immediate implant based breast reconstruction. Liposomal bupivacaine is a new formulation of the local anesthetic bupivacaine that may last longer and may control pain better compared to bupivacaine in the postoperative period after mastectomy and breast reconstruction.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03722927.
PRIMARY OBJECTIVE:
I. To evaluate the effect of liposomal bupivacaine (Exparel) on mean postoperative pain levels in patients who have undergone mastectomy and breast reconstruction within the first 48 hours.
SECONDARY OBJECTIVES:
I. To evaluate the effect of liposomal bupivacaine on cumulative pain control within the first 48 hours after mastectomy and breast reconstruction.
II. To evaluate the effect of liposomal bupivacaine on the amount of postoperative narcotic use after mastectomy and breast reconstruction for the first month after surgery.
III. To evaluate the effect of liposomal bupivacaine on length of hospital stay after mastectomy and breast reconstruction.
IV. To evaluate the effect of liposomal bupivacaine on hospital readmission rates a within 2 months after mastectomy and breast reconstruction.
V. To evaluate the effect of liposomal bupivacaine on the occurrence of opioid adverse effects within the first week of surgery after mastectomy and breast reconstruction.
VI. To evaluate the effect of liposomal bupivacaine on the trajectory of postoperative pain control within 2 months after mastectomy and breast reconstruction.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: After undergoing mastectomy, patients receive local infiltration of bupivacaine before undergoing tissue expander implant breast reconstruction.
GROUP II: After undergoing mastectomy, patients receive local infiltration of liposomal bupivacaine before undergoing tissue expander implant breast reconstruction.
After completion of study treatment, patients are followed up at 1, 3, and 5 weeks.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorChristopher Michael Runyan