Department of Anesthesiology, Prasat Neurological Institute, 312, Ratchawithi Road, Thung Phaya Thai, Ratchathewi, Bangkok, 10400, Thailand.
F1000Res. 2020 Jun 4;9:516. doi: 10.12688/f1000research.22909.2. eCollection 2020.
The incidence of moderate to severe pain is high among patients undergoing spinal surgery. Nefopam can be used as an adjuvant analgesic postoperatively after spine surgery. The study aimed to assess the analgesic efficacy and side effects of nefopam on 24-hour postoperative morphine consumption after spine surgery. The study is a randomized, double-blinded, placebo-controlled trial. A total of 96 patients were randomized into 4 treatment groups, 24 each. In group 1, patients received normal saline before surgical incision and before the end of surgery. In group 2, patients received 30 mg nefopam before surgical incision and normal saline before the end of surgery. In group 3, patients received normal saline before surgical incision and 30 mg of nefopam before the end of surgery. In group 4, patients received 30 mg of nefopam in both timings. Patient-controlled analgesia morphine was used for the postoperative period. Outcomes were to determine 24-hour morphine consumption and incidence of side effects. Of 96 patients enrolled, 21 in placebo-placebo, 22 in nefopam-placebo, 22 in placebo-nefopam and 21 in nefopam-nefopam groups completed the study. Analysis of the Kruskal-Wallis test shows no significant difference in 24-hour postoperative morphine consumption between four groups, which were 18 [IQR 13.5-29], 20 [IQR 11-28.3], 17 [IQR 11.5-28.5], 13 [IQR 8.5-18.5] mg., respectively (p = 0.223). Incidence of side effects, including tachycardia, sedation, sweating and nausea/ vomiting, did not differ. Adding perioperative nefopam to opioid analgesic does not improve analgesic efficacy in patients who underwent spine surgery. Thai Clinical Trials Registry ID TCTR20171115001; registered on 15 November 2017.
接受脊柱手术的患者中，中度至重度疼痛的发生率较高。盐酸奈福泮可作为脊柱手术后的辅助镇痛药物。本研究旨在评估盐酸奈福泮对脊柱手术后 24 小时内吗啡消耗量的镇痛效果和副作用。该研究为随机、双盲、安慰剂对照试验。共纳入 96 例患者，随机分为 4 个治疗组，每组 24 例。在第 1 组中，患者在手术切口前和手术结束前接受生理盐水；第 2 组患者在手术切口前接受 30mg 盐酸奈福泮，手术结束前接受生理盐水；第 3 组患者在手术切口前接受生理盐水，手术结束前接受 30mg 盐酸奈福泮；第 4 组患者在两个时间点均接受 30mg 盐酸奈福泮。患者术后使用自控镇痛吗啡。术后结果是确定 24 小时吗啡消耗量和副作用发生率。96 例患者中，21 例进入安慰剂-安慰剂组、22 例进入盐酸奈福泮-安慰剂组、22 例进入安慰剂-盐酸奈福泮组和 21 例进入盐酸奈福泮-盐酸奈福泮组完成了研究。Kruskal-Wallis 检验分析显示，四组患者术后 24 小时吗啡消耗量无显著差异，分别为 18[IQR 13.5-29]、20[IQR 11-28.3]、17[IQR 11.5-28.5]和 13[IQR 8.5-18.5]mg（p=0.223）。包括心动过速、镇静、出汗和恶心/呕吐在内的副作用发生率无差异。在接受脊柱手术的患者中，围手术期使用盐酸奈福泮联合阿片类镇痛药并不能提高镇痛效果。泰国临床试验注册中心注册号 TCTR20171115001；注册于 2017 年 11 月 15 日。
