BACKGROUND: Previously, it was shown that locally applied intraoperative ketorolac and bupivacaine significantly reduced pain in the recovery room. The objective of this study was to test the effectiveness of the same solution over the first 10 days. METHODS: This study was a prospective, randomized, double-blind clinical trial with ethical approval. Fifty submuscular breast augmentation patients were enrolled, and informed consent was obtained. Standard anesthetic and surgical protocols were followed. Either normal saline or ketorolac and bupivacaine (30 mg and 150 mg, respectively) were placed into the pocket. The power of this study to detect a 20 percent difference was 0.90, and values of p < 0.05 were considered significant. The primary outcome was pain measured with the visual analogue pain scale recorded in a take-home diary. The secondary outcome was codeine usage. RESULTS:Forty-five patients completed the study. Of the patients who did not, three were in the normal saline group (n = 22) and two were in the ketorolac-bupivacaine group (n = 23). The ketorolac-bupivacaine combination significantly reduced pain over the first 5 days. By the tenth day postoperatively, the effect had dissipated. These patients also used less codeine. There were no significant complications. CONCLUSION: Locally applied, intraoperative ketorolac and bupivacaine significantly reduced pain for 5 days after surgery in women who had undergone primary breast augmentation.
RCT Entities:
BACKGROUND: Previously, it was shown that locally applied intraoperative ketorolac and bupivacaine significantly reduced pain in the recovery room. The objective of this study was to test the effectiveness of the same solution over the first 10 days. METHODS: This study was a prospective, randomized, double-blind clinical trial with ethical approval. Fifty submuscular breast augmentationpatients were enrolled, and informed consent was obtained. Standard anesthetic and surgical protocols were followed. Either normal saline or ketorolac and bupivacaine (30 mg and 150 mg, respectively) were placed into the pocket. The power of this study to detect a 20 percent difference was 0.90, and values of p < 0.05 were considered significant. The primary outcome was pain measured with the visual analogue pain scale recorded in a take-home diary. The secondary outcome was codeine usage. RESULTS: Forty-five patients completed the study. Of the patients who did not, three were in the normal saline group (n = 22) and two were in the ketorolac-bupivacaine group (n = 23). The ketorolac-bupivacaine combination significantly reduced pain over the first 5 days. By the tenth day postoperatively, the effect had dissipated. These patients also used less codeine. There were no significant complications. CONCLUSION: Locally applied, intraoperative ketorolac and bupivacaine significantly reduced pain for 5 days after surgery in women who had undergone primary breast augmentation.
Authors: Kevin M Klifto; Ala Elhelali; Rachael M Payne; Carisa M Cooney; Michele A Manahan; Gedge D Rosson Journal: Cochrane Database Syst Rev Date: 2021-11-09