Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA 19107, USA.
Curr Med Res Opin. 2012 Aug;28(8):1323-35. doi: 10.1185/03007995.2012.707121. Epub 2012 Jul 16.
To evaluate the effects of two different doses of etoricoxib delivered perioperatively compared with placebo and standard pain management on pain at rest, pain with mobilization, and use of additional morphine/opioids postoperatively.
In this double-blind, placebo-controlled, randomized clinical trial, we evaluated postoperative pain following total abdominal hysterectomy over 5 days in patients receiving placebo or etoricoxib administered 90 min prior to surgery and continuing postoperatively. Patients were randomly assigned to receive either placebo (n = 144), etoricoxib 90 mg/day (n = 142), or etoricoxib 120 mg/day (n = 144). Average Pain Intensity at Rest over days 1-3 (0- to 10-point numerical rating scale [NRS]) was the primary efficacy endpoint. Secondary endpoints included Average Pain Intensity upon Sitting, Standing, and Walking over days 1-3 (0- to 10-point NRS) as well as Average Total Daily Dose of Morphine over days 1-3.
This trial is registered on www.clinicaltrials.gov (NCT00788710).
The least squares (LS) means (95% CI) for the primary endpoint were 3.26 (2.96, 3.55); 2.46 (2.16, 2.76); and 2.40 (2.11, 2.69) for placebo, etoricoxib 90 mg, and etoricoxib 120 mg, respectively, significantly different for both etoricoxib doses versus placebo (p < 0.001). Patients on etoricoxib 90 mg and 120 mg required ~30% less morphine per day than those on placebo (p < 0.001), which led to more rapid bowel recovery in the active treatment groups by ~10 hours vs. placebo. A greater proportion of patients on etoricoxib (10-30% greater than placebo) achieved mild levels of pain with movement, defined as pain ≤3/10.
A key limitation for this study was that movement-evoked pain measurements were not designated as primary endpoints.
In patients undergoing total abdominal hysterectomy, etoricoxib 90 mg and 120 mg dosed preoperatively and then continued postoperatively significantly reduces both resting and movement-related pain, as well as reduced opioid (morphine) consumption that led to more rapid bowel recovery.
评估两种不同剂量的依托考昔在围手术期与安慰剂和标准疼痛管理相比对术后静息痛、活动痛和额外吗啡/阿片类药物使用的影响。
在这项双盲、安慰剂对照、随机临床试验中，我们评估了接受安慰剂或手术前 90 分钟给予依托考昔并持续术后给药的患者在接受全子宫切除术 5 天后的术后疼痛。患者被随机分配接受安慰剂（n=144）、依托考昔 90mg/天（n=142）或依托考昔 120mg/天（n=144）。第 1-3 天（0-10 分数字评分量表[NRS]）的平均静息疼痛强度是主要疗效终点。次要终点包括第 1-3 天（0-10 分 NRS）的平均坐立、站立和行走时疼痛强度以及第 1-3 天的平均每日吗啡总剂量。
本试验在 www.clinicaltrials.gov 上注册（NCT00788710）。
主要终点的最小二乘（LS）均值（95%CI）分别为安慰剂组 3.26（2.96，3.55）、依托考昔 90mg 组 2.46（2.16，2.76）和依托考昔 120mg 组 2.40（2.11，2.69），依托考昔 90mg 和 120mg 剂量组与安慰剂组相比均有显著差异（p<0.001）。与安慰剂组相比，依托考昔 90mg 和 120mg 组每天需要的吗啡量减少约 30%（p<0.001），这导致在活跃治疗组中，肠功能恢复更快，约提前 10 小时。与安慰剂相比，更多的依托考昔（比安慰剂高 10-30%）患者达到轻度运动相关疼痛水平，定义为疼痛≤3/10。
本研究的一个关键局限性是运动诱发疼痛测量未被指定为主要终点。
在接受全子宫切除术的患者中，术前给予依托考昔 90mg 和 120mg 剂量，然后持续术后给药可显著减轻静息和运动相关疼痛，并减少阿片类药物（吗啡）的消耗，从而更快地恢复肠功能。
