J Neurosurg. 2018 Feb;128(2):444-451. doi: 10.3171/2016.10.JNS161355. Epub 2017 Mar 3.
OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p < 0.0001). Opioid use was significantly different, with a 58% reduction in Group 1 (26.3 ± 28.7 mg OME) compared with Group 2 (62.5 ± 63.8 mg OME; p < 0.0001). CONCLUSIONS Multimodal opioid-minimizing pain-management protocols resulted in acceptable pain control following transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials.gov) ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized, controlled trial; evidence: Class III.
疼痛控制是一个重要的临床关注点和护理质量指标。目前还没有研究探讨经蝶窦手术治疗垂体病变后的术后疼痛控制情况。本研究的目的是：1）报告经蝶窦手术后的术后疼痛评分；2）确定多模式阿片类药物最小化疼痛方案是否能获得满意的术后疼痛控制；3）确定静脉（IV）布洛芬与安慰剂相比是否能改善术后疼痛评分并减少阿片类药物的使用。方法：这是一项单中心、随机、双盲、安慰剂对照的干预试验，涉及计划接受经蝶窦垂体肿瘤切除术的成年患者，随机分为 2 组。第 1 组患者接受计划的 IV 布洛芬、计划的口服对乙酰氨基酚和阿片类药物解救治疗。第 2 组患者接受 IV 安慰剂、计划的口服对乙酰氨基酚和阿片类药物解救治疗。主要终点是术后 48 小时患者的疼痛评分（视觉模拟评分[VAS]，评分为 0-10）。次要终点是通过口服吗啡等效物（OME）估计的阿片类药物使用量。结果：在筛选的 136 名患者中，有 62 名患者入组（第 1 组 28 名，第 2 组 34 名）。由于达到了主要和次要终点，该研究提前终止。除年龄外，两组间的基线特征匹配良好（第 1 组，59.3±14.4 岁；第 2 组，49.8±16.2 岁；p=0.02）。VAS 疼痛评分有显著差异，第 1 组的疼痛评分降低了 43%（1.7±2.2），而第 2 组的疼痛评分降低了 30%（3.0±2.8；p＜0.0001）。阿片类药物的使用量也有显著差异，第 1 组的使用量降低了 58%（26.3±28.7mg OME），而第 2 组的使用量降低了 62%（62.5±63.8mg OME；p＜0.0001）。结论：多模式阿片类药物最小化疼痛管理方案可实现经蝶窦手术后的可接受的疼痛控制。与安慰剂相比，静脉注射布洛芬可显著改善疼痛评分并显著减少阿片类药物的使用。术后应考虑多模式疼痛管理，包括非甾体类抗炎药，以改善患者舒适度并限制阿片类药物的使用。临床试验注册号：NCT02351700（clinicaltrials.gov）■ 证据分类：治疗性问题；研究设计：随机对照试验；证据等级：III 级。
