Methods: A prospective, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following implant based breast reconstruction was performed. This study consisted of two arms of patients undergoing immediate unilateral or bilateral implant based breast reconstruction. Patients in the control arm were treated intra-operatively with injections with 0.25% bupivacaine and epinephrine, with 20 mL delivered into each breast pocket to perform a field block of the breast pocket. Patients in the experimental arm were treated intra-operatively with one 20 mL, 266 mg vial of 1.3% liposomal bupivacaine, with 10 mL delivered to each breast pocket. Pain medications were converted to morphine equivalents to calculate total opioid usage per hospital stay. Length of stay and other direct cost data was collected over the entire post operative period. Basic statistical analyses consisted of a t-test for average length of stay and average opioid consumption with p= 0.05 being utilized to ascertain statistical significance.
Results: Ten patients have been enrolled prior to this interim analysis. Six women were randomized to the control arm and four women were randomized to the experimental arm. On average, women in the control arm had a longer length of stay (46.0 hours) compared to women in the treatment arm (34.6 hours). Total opioid usage per hospital stay was higher for women in the control arm (152.5 mg) compared to women in the experimental arm (131.4 mg). A direct cost differential was measured.
Conclusion: Early interim analysis suggests that liposomal bupivacaine has the potential to reduce opioid consumption, length of stay, and direct costs. Patient recruitment and data collection is ongoing.