Mahabir Raman C, Peterson Brian D, Williamson J Scott, Valnicek Stan M, Williamson David G, East William E
Kelowna, British Columbia, Canada From the Division of Plastic and Reconstructive Surgery, and the Department of Anesthesia, Okanagan Health Surgical Unit, University of British Columbia, and the Kelowna General Hospital.
Plast Reconstr Surg. 2008 Feb;121(2):638-643. doi: 10.1097/01.prs.0000298112.52389.e1.
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.
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.
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.
Locally applied, intraoperative ketorolac and bupivacaine significantly reduced pain for 5 days after surgery in women who had undergone primary breast augmentation.
此前研究表明，术中局部应用酮咯酸和布比卡因可显著减轻恢复室中的疼痛。本研究的目的是测试同一溶液在术后前10天的有效性。
本研究是一项经伦理批准的前瞻性、随机、双盲临床试验。纳入50例肌下隆乳患者，并获得知情同意。遵循标准的麻醉和手术方案。将生理盐水或酮咯酸和布比卡因（分别为30毫克和150毫克）注入腔隙。本研究检测20%差异的效能为0.90，p<0.05的值被认为具有显著性。主要结局是用带回家的日记中记录的视觉模拟疼痛量表测量的疼痛。次要结局是可待因的使用情况。
45例患者完成了研究。未完成研究的患者中，生理盐水组（n=22）有3例，酮咯酸-布比卡因组（n=23）有2例。酮咯酸-布比卡因联合用药在术后前5天显著减轻了疼痛。到术后第10天，效果消失。这些患者的可待因使用量也较少。无显著并发症。
对于接受初次隆乳手术的女性，术中局部应用酮咯酸和布比卡因可在术后5天显著减轻疼痛。
