Crisp Catrina C, Khan Madiha, Lambers Donna L, Westermann Lauren B, Mazloomdoost Donna M, Yeung Jennifer J, Kleeman Steven D, Pauls Rachel N
From the *Division of Urogynecology and Female Reconstructive Surgery, †Department of Obstetrics and Gynecology; and ‡Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, TriHealth Good Samaritan Hospital, Cincinnati, OH.
Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347.
This study aimed to determine the effect of intravenous acetaminophen versus placebo on postoperative pain, satisfaction with pain control, and narcotic use after vaginal reconstructive surgery.
This was an institutional review board-approved, double-blind placebo-controlled randomized trial. Women scheduled for reconstructive surgery including vaginal hysterectomy and vaginal vault suspension were enrolled. Subjects received 1000 mg of intravenous acetaminophen or 100 mL placebo every 6 hours for 24 hours. Pain and satisfaction with pain control were assessed using visual analog scales and a numeric rating scale. Visual analog scales were collected at 18 and 24 hours postoperatively and at discharge. A sample size calculation determined 90 subjects would be required to detect a 30% reduction in postoperative narcotic use with 80% power and significance level of 0.05.
One hundred subjects were enrolled. There were no differences in demographics or surgical data and no difference in narcotic consumption at multiple evaluation points. At 18 hours postoperative, median pain scores at rest were 27.0 (interquartile range, 35.0) for acetaminophen and 35.0 (interquartile range, 44.5) for placebo, finding no difference (P = 0.465). Furthermore, pain with activity and numeric rating scale-assessed pain scales were similar (P = 0.328; P = 0.597). Although satisfaction with pain control was high overall (91.5), no difference was noted.
Patients undergoing vaginal reconstructive surgery receiving perioperative intravenous acetaminophen did not experience a decrease in narcotic requirements or postoperative pain when compared with placebo. Reassuringly, pain scores were low and satisfaction with pain control was high for all subjects. The general use of this medication is not supported in these surgical patients.
本研究旨在确定静脉注射对乙酰氨基酚与安慰剂相比，对阴道重建手术后的术后疼痛、疼痛控制满意度及麻醉药物使用的影响。
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。纳入计划进行包括阴道子宫切除术和阴道穹窿悬吊术在内的重建手术的女性。受试者每6小时接受1000mg静脉注射对乙酰氨基酚或100mL安慰剂，共24小时。使用视觉模拟量表和数字评分量表评估疼痛及疼痛控制满意度。术后18小时、24小时及出院时收集视觉模拟量表数据。样本量计算确定需要90名受试者才能以80%的检验效能和0.05的显著性水平检测到术后麻醉药物使用减少30%。
共纳入100名受试者。人口统计学或手术数据无差异，多个评估点的麻醉药物消耗量也无差异。术后18小时，对乙酰氨基酚组静息时的中位疼痛评分为27.0（四分位间距，35.0），安慰剂组为35.0（四分位间距，44.5），差异无统计学意义（P = 0.465）。此外，活动时疼痛及数字评分量表评估的疼痛量表结果相似（P = 0.328；P = 0.597）。尽管总体上对疼痛控制的满意度较高（91.5），但未发现差异。
与安慰剂相比，接受围手术期静脉注射对乙酰氨基酚的阴道重建手术患者的麻醉药物需求量或术后疼痛并未减少。令人欣慰的是，所有受试者的疼痛评分较低且对疼痛控制的满意度较高。不支持在这些手术患者中常规使用该药物。
