METHODS: This randomized controlled study enrolled 80 female patients scheduled for laparoscopic hysterectomy who were assigned randomly into 2 equal groups in 1:1; aripiprazole group (n = 40), patients received an aripiprazole 30 mg tablet orally 3 hours before surgery and placebo group (n = 40), patients received a placebo tablet 3 hours before surgery. The 24-hour morphine consumption postoperatively was the primary outcome, and the time to the first analgesic request, sedation scores, and the incidence of perioperative adverse events were the secondary outcomes.
RESULTS: The mean 24-hour morphine consumption was significantly lower with aripiprazole (2.5 ± 0.5 mg) than with placebo (23.7 ± 1.6 mg; mean ± SE -21.2 ± 0.3, 95% CI: -21.7 to -20.6, P < 0.001). In addition, the mean time to the first analgesic request was significantly longer with aripiprazole (212.2 ± 14.7 min) than with placebo (27.0 ± 2.0 min; mean ± SE 185.2 ± 2.3, 95% CI: 180.5 to 189.8, P < 0.001). Furthermore, the aripiprazole group reported higher sedation scores ( P < 0.001). Bradycardia and hypotension were reported more frequently among patients in the aripiprazole group ( P < 0.05).
CONCLUSIONS: Aripiprazole was effective in reducing pain after laparoscopic hysterectomy. Although self-limited, side effects should be taken into consideration when using the medication perioperatively.
方法:这项随机对照研究招募了80名计划进行腹腔镜子宫切除术的女性患者,他们以1:1的比例随机分为两组;阿立哌唑组(n=40):患者在手术前3小时口服阿立哌唑30mg片剂,安慰剂组(n=40):患者在手术前3小时接受安慰剂片。术后24小时服用吗啡是主要结果,以及第一次镇痛请求的时间,镇静评分,围手术期不良事件的发生率是次要结局.
结果:阿立哌唑(2.5±0.5mg)的平均24小时吗啡消耗量明显低于安慰剂(23.7±1.6mg)(平均值±SE-21.2±0.3,95%CI:-21.7至-20.6,P<0.001)。此外,阿立哌唑首次镇痛平均时间(212.2±14.7min)明显长于安慰剂组(27.0±2.0min)(平均值±SE185.2±2.3,95%CI:180.5~189.8,P<0.001).此外,阿立哌唑组的镇静评分较高(P<0.001).阿立哌唑组患者的心动过缓和低血压发生率更高(P<0.05)。
结论:阿立哌唑可有效减轻腹腔镜子宫切除术后的疼痛。虽然自我限制,围手术期使用药物时应考虑副作用。