Aloia Thomas A, Kim Bradford J, Segraves-Chun Yun Shin, Cata Juan P, Truty Mark J, Shi Qiuling, Holmes Alexander, Soliz Jose M, Popat Keyuri U, Rahlfs Thomas F, Lee Jeffrey E, Wang Xin Shelley, Morris Jeffrey S, Gottumukkala Vijaya N R, Vauthey Jean-Nicolas
*Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX †Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX ‡Department of Surgery, Mayo Clinic, Rochester, MN §Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX ¶Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386.
The primary objective of this randomized trial was to compare thoracic epidural analgesia (TEA) to intravenous patient-controlled analgesia (IV-PCA) for pain control over the first 48 hours after hepatopancreatobiliary (HPB) surgery. Secondary endpoints were patient-reported outcomes, total narcotic utilization, and complications.
Although adequate postoperative pain control is critical to patient and surgeon success, the optimal analgesia regimen in HPB surgery remains controversial.
Using a 2.5:1 randomization strategy, 140 patients were randomized to TEA (N = 106) or intravenous patient-controlled analgesia (N = 34). Patient-reported pain was measured on a Likert scale (0-10) at standard time intervals. Cumulative pain area under the curve was determined using the trapezoidal method.
Between the study groups key demographic, comorbidity, clinical, and operative variables were equivalently distributed. The median area under the curve of the postoperative time 0- to 48-hour pain scores was lower in the TEA group (78.6 vs 105.2 pain-hours, P = 0.032) with a 35% reduction in patients experiencing ≥7/10 pain (43% vs 62%, P = 0.07). Patient-reported outcomes and total opiate use further supported the benefit of TEA on patient experience. Anesthesia-related events requiring change in analgesic therapy were comparable (12.2% vs 2.9%, respectively, P = 0.187). Grade 3 or higher surgical complications (6.6% vs 9.4%), median length of stay (6 days vs 6 days), readmission (1.9% vs 3.1%), and return to the operating room (0.9% vs 3.1%) were similar (all P > 0.05). There were no mortalities in either group.
In major HPB surgery, TEA provides a superior patient experience through improved pain control and less narcotic use, without increased length of stay or complications.
本随机试验的主要目的是比较肝胰胆（HPB）手术后48小时内，胸段硬膜外镇痛（TEA）与静脉自控镇痛（IV-PCA）对疼痛的控制效果。次要终点包括患者报告的结局、总麻醉药物使用量及并发症。
尽管术后充分的疼痛控制对患者和外科医生的成功至关重要，但HPB手术的最佳镇痛方案仍存在争议。
采用2.5:1的随机化策略，将140例患者随机分为TEA组（N = 106）和静脉自控镇痛组（N = 34）。在标准时间间隔，采用李克特量表（0 - 10）测量患者报告的疼痛程度。使用梯形法确定疼痛曲线下的累积面积。
研究组间关键的人口统计学、合并症、临床及手术变量分布均衡。TEA组术后0至48小时疼痛评分曲线下面积中位数较低（78.6对105.2疼痛小时，P = 0.032），疼痛≥7/10的患者减少35%（43%对62%，P = 0.07）。患者报告的结局和总阿片类药物使用情况进一步支持了TEA对患者体验的益处。需要改变镇痛治疗的麻醉相关事件相当（分别为12.2%对2.9%，P = 0.187）。3级或更高等级的手术并发症（6.6%对9.4%）、中位住院时间（6天对6天）、再次入院率（1.9%对3.1%）及返回手术室的比例（0.9%对3.1%）相似（均P > 0.05）。两组均无死亡病例。
在大型HPB手术中，TEA通过改善疼痛控制和减少麻醉药物使用，提供了更好的患者体验，且不增加住院时间或并发症。
