Division of Maternal-Fetal Medicine and the Deborah Kelly Center for Outcomes Research, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts; Providence Anesthesia Services, Spokane, Washington; and the Department of Anesthesia, Critical Care, and Pain Medicine and the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Obstet Gynecol. 2018 Jul;132(1):70-78. doi: 10.1097/AOG.0000000000002649.
To evaluate whether a liposomal bupivacaine incisional block decreases postoperative pain and represents an opioid-minimizing strategy after scheduled cesarean delivery.
In a single-blind, randomized controlled trial among opioid-naive women undergoing cesarean delivery, liposomal bupivacaine or placebo was infiltrated into the fascia and skin at the surgical site, before fascial closure. Using an 11-point numeric rating scale, the primary outcome was pain score with movement at 48 hours postoperatively. A sample size of 40 women per group was needed to detect a 1.5-point reduction in pain score in the intervention group. Pain scores and opioid consumption, in oral morphine milligram equivalents, at 48 hours postoperatively were summarized as medians (interquartile range) and compared using the Wilcoxon rank-sum test.
Between March and September 2017, 249 women were screened, 103 women enrolled, and 80 women were randomized. One woman in the liposomal bupivacaine group was excluded after randomization as a result of a vertical skin incision, leaving 39 patients in the liposomal bupivacaine group and 40 in the placebo group. Baseline characteristics between groups were similar. The median (interquartile range) pain score with movement at 48 hours postoperatively was 4 (2-5) in the liposomal bupivacaine group and 3.5 (2-5.5) in the placebo group (P=.72). The median (interquartile range) opioid use was 37.5 (7.5-60) morphine milligram equivalents in the liposomal bupivacaine group and 37.5 (15-75) morphine milligram equivalents in the placebo group during the first 48 hours postoperatively (P=.44).
Compared with placebo, a liposomal bupivacaine incisional block at the time of cesarean delivery resulted in similar postoperative pain scores in the first 48 hours postoperatively.
ClinicalTrials.gov, NCT02959996.
评估脂质体布比卡因切口阻滞是否能减轻剖宫产术后疼痛，并在计划性剖宫产中减少阿片类药物的使用。
在一项针对接受剖宫产术的阿片类药物初治女性的单盲、随机对照试验中，在缝合筋膜前，将脂质体布比卡因或安慰剂注入切口的筋膜和皮肤。主要结局为术后 48 小时时的运动时疼痛评分，采用 11 点数字评分量表进行评估。研究需要每组 40 名女性才能检测到干预组疼痛评分降低 1.5 分。术后 48 小时时的疼痛评分和口服吗啡毫克当量数的阿片类药物消耗量总结为中位数（四分位间距），并采用 Wilcoxon 秩和检验进行比较。
2017 年 3 月至 9 月期间，共筛查了 249 名女性，有 103 名女性入组，80 名女性被随机分组。1 名接受脂质体布比卡因组的女性因垂直皮肤切口而在随机分组后被排除，因此脂质体布比卡因组有 39 名患者，安慰剂组有 40 名患者。两组间的基线特征相似。术后 48 小时时运动时的疼痛评分中位数（四分位间距）在脂质体布比卡因组为 4（2-5）分，在安慰剂组为 3.5（2-5.5）分（P=0.72）。脂质体布比卡因组术后 48 小时内的阿片类药物中位数（四分位间距）使用量为 37.5（7.5-60）吗啡毫克当量，安慰剂组为 37.5（15-75）吗啡毫克当量（P=0.44）。
与安慰剂相比，剖宫产时应用脂质体布比卡因切口阻滞在术后 48 小时内并未导致术后疼痛评分明显降低。
ClinicalTrials.gov，NCT02959996。
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