This randomized phase II trial studies liposomal bupivacaine or bupivacaine hydrochloride in reducing pain in patients undergoing breast reconstruction using their own abdominal tissue (autologous). Liposomal bupivacaine and bupivacaine hydrochloride are used as local analgesic (pain relieve) by blocking signals at nerve endings and may be effective in providing pain relieve to the abdominal area where tissue is removed. Liposomal bupivacaine, however, works for up to 72 hours after surgery and may require less pain medications after abdominal based autologous breast reconstruction.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02662036.
PRIMARY OBJECTIVES:
I. To evaluate the analgesic effectiveness of liposomal bupivacaine (Exparel) versus bupivacaine hydrochloride (HCl) as a transverse abdominis tissue plane (TAP) block in women who have received abdominal-based autologous breast reconstruction measured by total opioid use during the hospital stay.
SECONDARY OBJECTIVES:
I. To evaluate the analgesic effectiveness of liposomal bupivacaine (Exparel) as a TAP block versus bupivacaine HCl as a TAP block in women who have received abdominal-based autologous breast reconstruction as measured by: total antiemetic use during the hospital stay; length of hospital stay; time until ambulation; time until urinary catheter removal; pain scores; and patient satisfaction with recovery.
II. To evaluate the cost of liposomal bupivacaine (Exparel) versus bupivacaine HCl when accounting for length of hospital stay and use of other analgesics.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP I: Patients receive bupivacaine hydrochloride via TAP block into the abdominal surgical site.
GROUP II: Patients receive liposomal bupivacaine via a TAP block into the abdominal surgical site.
After completion of study treatment, patients are followed up to 2-6 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorTerrence Myckatyn
