Altenau Brie, Crisp Catrina C, Devaiah C Ganga, Lambers Donna S
Department of Obstetrics and Gynecology, TriHealth Hospitals, Cincinnati, OH.
Division of Female Pelvic Medicine and Reconstructive Surgery, TriHealth Hospitals, Cincinnati, OH.
Am J Obstet Gynecol. 2017 Sep;217(3):362.e1-362.e6. doi: 10.1016/j.ajog.2017.04.030. Epub 2017 Apr 25.
Cesarean delivery is a common surgery in the United States, with 1.3 million performed during 2009. Obstetricians must balance the growing concern with opioid abuse, dependence, and side effects with optimal postoperative pain control. Intravenous acetaminophen may represent an additional method to decrease the reliance on opioid medications and improve postoperative pain following cesarean delivery.
The objective of the study was to determine whether the administration of intravenous acetaminophen following routine scheduled cesarean delivery would decrease the need for narcotic medications to control postoperative pain.
This was an institutional review board-approved, double-blind, placebo-controlled, randomized trial, registered on clinicaltrials.gov (number 02046382). Women scheduled to undergo cesarean delivery with regional anesthesia at term were recruited. All perioperative and postpartum care was standardized via study order sets. Study patients were given all medications in a standardized manner receiving either acetaminophen 1000 mg intravenously or 100 mL saline (placebo) every 8 hours for 48 hours for a total of 6 doses. The pharmacy prepared intravenous acetaminophen and saline in identical administration bags labeled study drug to ensure blinding. The initial dose of study drug was given within 60 minutes of skin incision. Quantity of breakthrough and scheduled analgesic medications and self-reported pain levels on the Faces Pain Scale (0-10) before and after study drug administration were collected. Patient demographics were extracted from the chart. Power calculation determined that 45 patients per arm were required to detect a 30% reduction in postcesarean narcotic requirement with 80% power and a significance level of P = .05.
A total of 133 patients were consented for the study. Twenty-nine were excluded and 104 patients completed the study: 57 received intravenous acetaminophen and 47 received placebo. There were no differences in baseline demographic characteristics including patient age, body mass index, gravidity, parity, race, comorbidities, or number of prior cesarean deliveries. There were no differences between groups in estimated blood loss or length of stay. The total amount of oral narcotic medications consumed by patients receiving intravenous acetaminophen was significantly reduced when compared with the placebo group (47 mg vs 65 mg of oxycodone; P = .034). The total amount of ibuprofen used between groups was not different. There was no difference in pain scores between groups before and after study dose administration. There was no significant difference in narcotic side effects (nausea/emesis, respiratory depression, constipation) in either study arm.
Intravenous acetaminophen in the postoperative period following cesarean delivery resulted in a significant decrease in oral narcotic consumption for pain control.
剖宫产在美国是一种常见的手术，2009年有130万例。产科医生必须在对阿片类药物滥用、依赖和副作用日益增长的担忧与最佳术后疼痛控制之间取得平衡。静脉注射对乙酰氨基酚可能是一种减少对阿片类药物依赖并改善剖宫产术后疼痛的额外方法。
本研究的目的是确定在常规择期剖宫产后给予静脉注射对乙酰氨基酚是否会减少控制术后疼痛所需的麻醉药物。
这是一项经机构审查委员会批准的双盲、安慰剂对照、随机试验，已在clinicaltrials.gov上注册（编号02046382）。招募了计划在足月时接受区域麻醉进行剖宫产的女性。所有围手术期和产后护理均通过研究医嘱集进行标准化。研究患者以标准化方式接受所有药物治疗，每8小时静脉注射1000 mg对乙酰氨基酚或100 mL生理盐水（安慰剂），共48小时，总计6剂。药房将静脉注射对乙酰氨基酚和生理盐水制备在相同的给药袋中，并标记为研究药物以确保盲法。研究药物的初始剂量在皮肤切开后60分钟内给予。收集研究药物给药前后突破性和预定镇痛药物的用量以及面部疼痛量表（0-10）上的自我报告疼痛水平。从病历中提取患者人口统计学数据。功效计算确定每组需要45名患者，以80%的功效和P = 0.05的显著性水平检测剖宫产后麻醉需求降低30%。
共有133名患者同意参加本研究。29名被排除，104名患者完成研究：57名接受静脉注射对乙酰氨基酚，47名接受安慰剂。在包括患者年龄、体重指数、妊娠次数、产次、种族、合并症或既往剖宫产次数在内的基线人口统计学特征方面没有差异。两组之间的估计失血量或住院时间没有差异。与安慰剂组相比，接受静脉注射对乙酰氨基酚的患者口服麻醉药物的总消耗量显著减少（47 mg对65 mg羟考酮；P = 0.034）。两组之间布洛芬的使用总量没有差异。研究剂量给药前后两组的疼痛评分没有差异。任一研究组中麻醉副作用（恶心/呕吐、呼吸抑制、便秘）均无显著差异。
剖宫产术后静脉注射对乙酰氨基酚可显著减少用于疼痛控制的口服麻醉药物用量。
