N. Hirasawa, K. Kurosaka, M. Nishino, S. Tsukada, Department of Orthopaedic Surgery, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan T. Nakayama, Department of Rehabilitation, Hokusuikai Kinen Hospital, Mito, Ibaraki, Japan M. Matsubara, Department of Orthopaedic Surgery, Nissan Tamagawa Hospital, Tokyo, Japan.
Clin Orthop Relat Res. 2018 Sep;476(9):1837-1845. doi: 10.1097/CORR.0000000000000374.
Periarticular analgesic injection (PAI) is being used more commonly for pain relief after orthopaedic surgeries. However, there is conflicting evidence regarding the effectiveness of PAI for post-THA pain relief.
QUESTIONS/PURPOSES: In a double-blind, randomized, controlled trial among patients undergoing same-day bilateral THA, with each patient serving as his or her own control, we asked: (1) Did the pain score as measured on a 100-mm VAS differ between the hips that received PAI versus placebo? (2) Were there differences in complications between the treatment and control hips in these patients?
Over a 1-year period at one center, 45 patients underwent same-day bilateral THA; three were excluded for prespecified reasons, and two declined participation in this randomized, controlled trial, leaving 40 patients (80 THAs) in the study. Patients randomly received PAI in one hip and placebo in the contralateral hip; patients, surgeons, and nurses were blinded in terms of which hip received the PAI and which hip received a placebo saline injection. The PAI solution included ropivacaine, morphine hydrochloride hydrate, methylprednisolone, ketoprofen, and epinephrine. The primary outcome was the VAS for pain at rest 24 hours after THA, measured using a 100-mm horizontal VAS. The VAS score was compared between two groups and assessed to reach the reported threshold values for the minimum clinically important difference (MCID) of 20 mm for the postoperative VAS score. No patients were lost to followup, and there were no missing data for the primary outcome. Complications that occurred during the trial were recorded prospectively with emphasis on infection, wound complications, nerve palsy and allergic reactions to the injections.
There were no clinically important differences between hips treated with the PAI and those treated with the placebo injection at any point. The hips that received PAI had less pain than those receiving placebo 24 hours after THA (16 ± 17 mm versus 22 ± 20 mm; mean difference, 6 mm; 95% confidence interval [CI], 2-9 mm; p = 0.006), but this effect size was below the MCID of 20 mm and thus is unlikely to be clinically important. The hips that received PAI also had better VAS scores in the recovery room (38 ± 29 mm versus 52 ± 33 mm; mean difference 14 mm; 95% CI, 5-23 mm; p = 0.004) and 3 hours after THA than placebo controls (28 ± 22 mm versus 37 ± 24 mm; mean difference 9 mm; 95% CI, 2-16 mm; p = 0.010). Neither of these differences exceeded the MCID and likewise were unlikely to be clinically important. No complications, including surgical site infections, were observed in either group.
Periarticular analgesic injection for pain control after THA did not result in a clinically important reduction in pain at any point examined. Given the expense associated with this PAI mixture and the lack of effectiveness outside this timeframe, we cannot recommend its use. Other mixtures or concentrations of drugs may be helpful in short-stay admissions for THA, but this will require further research.
Level I, therapeutic study.
关节周围镇痛注射（PAI）在骨科手术后用于缓解疼痛的情况越来越普遍。然而，对于 PAI 缓解 THA 后疼痛的有效性，目前存在相互矛盾的证据。
问题/目的：在一项针对同一天接受双侧 THA 的患者进行的双盲、随机、对照试验中，每位患者均作为自身对照，我们提出了以下问题：（1）接受 PAI 与安慰剂的髋关节之间，100mm VAS 测量的疼痛评分是否存在差异？（2）在这些患者中，治疗组和对照组的髋关节之间是否存在并发症差异？
在一个中心的 1 年期间，有 45 名患者接受了同一天的双侧 THA；由于规定的原因，有 3 名患者被排除在外，有 2 名患者拒绝参与这项随机对照试验，因此这项研究中共有 40 名患者（80 个髋关节）。患者随机接受一侧髋关节的 PAI 和对侧髋关节的安慰剂生理盐水注射；患者、外科医生和护士在接受 PAI 和接受安慰剂盐水注射的髋关节方面均处于盲态。PAI 溶液包括罗哌卡因、盐酸氢吗啡酮、甲泼尼龙、酮咯酸和肾上腺素。主要结局是在 THA 后 24 小时使用 100mm 水平 VAS 测量的静息时疼痛的 VAS 评分。比较两组之间的 VAS 评分，并评估是否达到术后 VAS 评分的最小临床重要差异（MCID）的 20mm 报告阈值。没有患者失访，主要结局没有缺失数据。在试验过程中记录了前瞻性发生的并发症，重点是感染、伤口并发症、神经麻痹和对注射的过敏反应。
在任何时间点，接受 PAI 治疗的髋关节与接受安慰剂注射治疗的髋关节之间均无临床重要差异。接受 PAI 的髋关节在 THA 后 24 小时的疼痛程度低于接受安慰剂的髋关节（16±17mm 与 22±20mm；平均差异 6mm；95%置信区间 [CI]，2-9mm；p=0.006），但这种效应大小低于 20mm 的 MCID，因此不太可能具有临床意义。接受 PAI 的髋关节在恢复室（38±29mm 与 52±33mm；平均差异 14mm；95%CI，5-23mm；p=0.004）和 THA 后 3 小时（28±22mm 与 37±24mm；平均差异 9mm；95%CI，2-16mm；p=0.010）的 VAS 评分也更好。这两个差异都没有超过 MCID，同样不太可能具有临床意义。两组均未观察到任何并发症，包括手术部位感染。
THA 后关节周围镇痛注射控制疼痛并未在任何检查点导致疼痛的临床显著减轻。考虑到这种 PAI 混合物的费用以及在这段时间之外缺乏有效性，我们不能推荐其使用。其他混合物或药物浓度可能有助于 THA 的短期住院治疗，但这需要进一步研究。
I 级，治疗性研究。
