Department of Orthopedic Surgery, Spine Service, Hospital for Special Surgery, New York, NY.
Spine (Phila Pa 1976). 2024 Jan 15;49(2):73-80. doi: 10.1097/BRS.0000000000004831. Epub 2023 Sep 22.
A randomized, double-blinded, placebo-controlled trial.
To examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared with IV-placebo (IV-P) and IV acetaminophen (IV-A).
Controlling postoperative pain while minimizing opioid use after lumbar spinal fusion is an important area of study.
Patients aged 18 to 75 years undergoing 1 to 2 level lumbar fusions between April 2016 and December 2019 were included. Patients with chronic opioid use, smokers, and those on systemic glucocorticoids or contraindications to study medications were excluded. A block randomization scheme was used, and study personnel, hospital staff, and subjects were blinded to the assignment. Patients were randomized postoperatively. The IV-K group received 15 mg (age > 65) or 30 mg (age < 65) every six hours (q6h) for 48 hours, IV-A received 1000 mg q6h, and IV-P received normal saline q6h for 48 hours. Demographic and surgical details, opioid use in morphine milliequivalents, opioid-related adverse events, and length of stay (LOS) were recorded. The primary outcome was in-hospital opioid use up to 72 hours.
A total of 171 patients were included (58 IV-K, 55 IV-A, and 58 IV-P) in the intent-to-treat (ITT) analysis, with a mean age of 57.1 years. The IV-K group had lower opioid use at 72 hours (173 ± 157 mg) versus IV-A (255 ± 179 mg) and IV-P (299 ± 179 mg; P = 0.000). In terms of opiate use, IV-K was superior to IV-A ( P = 0.025) and IV-P ( P = 0.000) on ITT analysis, although on per-protocol analysis, the difference with IV-A did not reach significance ( P = 0.063). When compared with IV-P, IV-K patients reported significantly lower worst ( P = 0.004), best ( P = 0.001), average ( P = 0.001), and current pain ( P = 0.002) on postoperative day 1, and significantly shorter LOS ( P = 0.009) on ITT analysis. There were no differences in opioid-related adverse events, drain output, clinical outcomes, transfusion rates, or fusion rates.
By reducing opioid use, improving pain control on postoperative day 1, and decreasing LOS without increases in complications or pseudarthrosis, IV-K may be an important component of "enhanced recovery after surgery" protocols.
一项随机、双盲、安慰剂对照试验。
研究静脉注射酮咯酸(IV-K)与静脉注射安慰剂(IV-P)和静脉注射对乙酰氨基酚(IV-A)相比对术后阿片类药物使用的影响。
控制腰椎融合术后的疼痛,同时尽量减少阿片类药物的使用是一个重要的研究领域。
纳入 2016 年 4 月至 2019 年 12 月期间接受 1 至 2 个节段腰椎融合术的 18 至 75 岁患者。慢性阿片类药物使用者、吸烟者以及接受全身糖皮质激素或研究药物禁忌的患者被排除在外。采用块随机分组方案,研究人员、医院工作人员和受试者对分组均不知情。患者在术后随机分组。IV-K 组每 6 小时(q6h)接受 15mg(年龄>65 岁)或 30mg(年龄<65 岁),连续 48 小时;IV-A 组接受 1000mg q6h;IV-P 组接受生理盐水 q6h,连续 48 小时。记录人口统计学和手术细节、吗啡毫当量的阿片类药物使用、与阿片类药物相关的不良反应以及住院时间(LOS)。主要结局是 72 小时内的院内阿片类药物使用情况。
共有 171 名患者(58 名 IV-K、55 名 IV-A 和 58 名 IV-P)纳入意向治疗(ITT)分析,平均年龄为 57.1 岁。IV-K 组在 72 小时时的阿片类药物使用量较低(173±157mg),低于 IV-A(255±179mg)和 IV-P(299±179mg;P=0.000)。在阿片类药物使用方面,IV-K 在 ITT 分析中优于 IV-A(P=0.025)和 IV-P(P=0.000),尽管在方案治疗分析中,与 IV-A 的差异没有达到统计学意义(P=0.063)。与 IV-P 相比,IV-K 患者在术后第 1 天报告的最差(P=0.004)、最佳(P=0.001)、平均(P=0.001)和当前疼痛(P=0.002)明显更低,在 ITT 分析中 LOS 明显更短(P=0.009)。两组在阿片类药物相关不良反应、引流量、临床结局、输血率或融合率方面无差异。
通过减少阿片类药物的使用、改善术后第 1 天的疼痛控制以及缩短 LOS,而不增加并发症或假关节形成的风险,IV-K 可能成为“术后加速康复”方案的重要组成部分。