Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-blinded Randomized Controlled Trial

Subpectoral tissue expander breast reconstruction is often associated with muscle spasms, pain, and discomfort during tissue expansion. In this study, we hypothesized that an intraoperative injection of botulinum toxin A (BTX-A) in the pectoralis major muscle reduces the pain associated with tissue expansion and improves women’s physical well-being. METHODS: Between May 2012 and May 2017, women undergoing immediate subpectoral tissue expander breast reconstruction were randomized to administer 100 units of BTX-A or a placebo injection. A numeric pain intensity scale and the physical well-being scale of the BREAST-Q: Reconstruction Module were used to test our hypothesis. Data on postoperative oral narcotic consumption were not collected. RESULTS: Of the 131 women included in the analysis, 48% were randomized to placebo and 52% to BTX-A. The preoperative median pain intensity score was 0 [interquartile range (IQR), 0–1], and the median preoperative BREAST-Q score was 91 (IQR, 81–100). The median slopes for the change in pain intensity scores from baseline throughout tissue expansion for those randomized to placebo and BTX-A were −0.01 (IQR, −0.02 to 0.00) and −0.01 (IQR, −0.02 to 0.00), respectively (P = 0.55). The median slopes for the change in BREAST-Q scores from baseline throughout tissue expansion for those randomized to placebo and BTX-A were 0.04 (IQR, −0.17 to 0.14) and 0.02 (IQR, −0.06 to 0.13), respectively (P = 0.89). CONCLUSION: In this study, we found that an intraoperative intramuscular injection of 100 units of BTX-A in the pectoralis major muscle did not reduce postoperative pain and patient-reported physical well-being when compared with placebo.