依托考昔与低压气腹联合应用对比标准治疗用于腹腔镜胆囊切除术后疼痛管理的随机对照试验
Combination of etoricoxib and low-pressure pneumoperitoneum versus standard treatment for the management of pain after laparoscopic cholecystectomy: a randomized controlled trial.
作者信息
Ko-Iam Wasana, Paiboonworachat Sahataya, Pongchairerks Paisal, Junrungsee Sunhawit, Sandhu Trichak
机构信息
Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
出版信息
Surg Endosc. 2016 Nov;30(11):4800-4808. doi: 10.1007/s00464-016-4810-4. Epub 2016 Feb 23.
BACKGROUND AND OBJECTIVES
Postoperative pain is one of the significant problems in laparoscopic surgery, especially during the first 6-12 h. This randomized controlled trial aimed to investigate the effect of combined preemptive etoricoxib 120 mg and low-pressure pneumoperitoneum for the management of pain after laparoscopic cholecystectomy (LC).
PATIENTS AND METHODS
One hundred and twenty patients aged 18-75 with American Society of Anesthesiologists class I-II who were candidates for elective LC were recruited into the study. The patients were randomly divided into two groups, by 'block of four' randomization. The treatment group received preemptive etoricoxib 120 mg and intraabdominal pressure of 7 mmHg, and the control group received placebo and intraabdominal pressure of 14 mmHg. The postoperative pain score at rest was recorded utilizing a numeric rating scale at 1, 2, 6, 10, 14, 18, 22, and 24 h. Pain on movement/ambulation (cough) was also recorded at 6, 10, 14, 18, 22, and 24 h.
RESULTS
There were no significant differences in the baseline characteristics of the two groups. The pain scores of the treatment versus control group of abdominal pain and incisional pain were significant on movement. Abdominal pain scores of the treatment group were decreased 0.98 when compared with the control group (p = 0.017), and incisional pain scores were also decreased 0.99 (p = 0.001). The incidences of postoperative shoulder/back pain were statistically significant: 41.8 % vs. 66.7 % in the treatment and control group, respectively (p = 0.009). The postoperative hospital stay in the treatment group and control group was: 1 day = 96.4 and 75.0 %, >1 day = 3.6 and 25.0 %, respectively (p = 0.001).
CONCLUSIONS
A combination of preemptive etoricoxib and low-pressure pneumoperitoneum had significant effects in decreasing overall pain and the incidence of shoulder/back pain after LC and also shortened the hospital stay.
CLINICAL TRIALS REGISTRATION NUMBER
TCTR20140213001.
背景与目的
术后疼痛是腹腔镜手术中的重要问题之一，尤其是在术后最初的6 - 12小时内。本随机对照试验旨在研究术前联合使用120毫克依托考昔和低压气腹对腹腔镜胆囊切除术（LC）后疼痛管理的效果。
患者与方法
招募120例年龄在18 - 75岁、美国麻醉医师协会分级为I - II级且计划行择期LC的患者纳入研究。通过“4例一组”随机化方法将患者随机分为两组。治疗组接受术前120毫克依托考昔及7毫米汞柱的腹内压，对照组接受安慰剂及14毫米汞柱的腹内压。术后静息时的疼痛评分采用数字评分量表在1、2、6、10、14、18、22及24小时记录。活动/行走（咳嗽）时的疼痛也在6、10、14,、18、22及24小时记录。
结果
两组的基线特征无显著差异。治疗组与对照组在活动时腹痛和切口疼痛的疼痛评分有显著差异。治疗组的腹痛评分与对照组相比降低了0.98（p = 0.017），切口疼痛评分也降低了0.99（p = 0.001）。术后肩/背痛的发生率有统计学意义：治疗组和对照组分别为41.8%和66.7%（p = 0.009）。治疗组和对照组的术后住院时间分别为：1天 = 96.4%和75.0%，>1天 = 3.6%和25.0%（p = 0.001）。
结论
术前使用依托考昔与低压气腹联合在降低LC术后总体疼痛及肩/背痛发生率方面有显著效果，且缩短了住院时间。
临床试验注册号
TCTR20140213001。
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