Department of Anesthesiology, Hospital Tengku Ampuan Rahimah, Klang, Malaysia.
Clinical Research Centre, Hospital Tengku Ampuan Rahimah, Klang, Malaysia.
Trials. 2022 Oct 14;23(1):874. doi: 10.1186/s13063-022-06810-y.
BACKGROUND: The value of pulsed electromagnetic field (PEMF) in postoperative pain management, due to the inconsistent findings so far, remains unclear. We extended the evaluation of PEMF on postoperative pain and intravenous (IV) analgesic use to a group of post-appendicectomy Asian patients. METHODS: This is a double-blinded, randomized trial. Adults with a clinical diagnosis of acute appendicitis were enrolled. Patients were allocated randomly to receive an active-PEMF device or an inactive device after the surgery in addition to the standard postoperative pain management. The primary outcome measure was the 12-h cumulative postoperative pain intensity measured at four different time points using the visual analogue scale. The secondary outcome measure was the total amount of IV fentanyl used (in mg) via PCA over the first 12 postoperative hours. The primary analysis in this trial compared the two study groups for the reported cumulative pain score (both at rest and on movement) and the cumulative amount of IV fentanyl uses over the first 12 postoperative hours using the Wilcoxon rank sum test. Analyses were performed based on the intention-to-treat principal. Multiple imputation was used to handle the missing data assuming that the data were missing at random. FINDINGS: One hundred eighteen subjects were randomized; 58 were allocated to the active-PEMF group and 60 to the inactive control group. Pooled mean pain score of both intervention groups by time point declined in a similar fashion over the course of 12 postoperative hours. The 12-h cumulative postoperative pain score at rest and on movement did not differ significantly after the procedure. (W = 1832.5 ~ 1933.0, p-value 0.6192 ~ 0.2985 for resting pain score comparison; W = 1737.0 ~ 1804.5, p-value 0.9892 ~ 0.7296 for movement pain score comparison). For the secondary outcome measure of 12-h total fentanyl use, a comparison between the PEMF vs. placebo arm also revealed no statistically significant difference across all the 20 imputed datasets (W = 1676.5 ~ 1859.0, p-value 0.7344 ~ 0.5234). DISCUSSION: PEMF was not superior to placebo as an adjunct pain management for up to 12 h post-appendicectomy. Previously reported effect of PEMF on postoperative pain intensity and analgesia uses in similar surgical settings cannot be verified. TRIAL REGISTRATION: National Medical Research Register Malaysia (NMRR-15-670-25,805) and Thai Clinical Trials Registry (retrospectively registered on November 01, 2019, Study ID-TCTR20191102002).
背景:由于目前的研究结果不一致,脉冲电磁场(PEMF)在术后疼痛管理中的价值仍不清楚。我们将 PEMF 对术后疼痛和静脉(IV)镇痛使用的评估扩展到一组亚洲阑尾切除术后的患者。
方法:这是一项双盲、随机临床试验。纳入有急性阑尾炎临床诊断的成年人。手术后,患者被随机分配接受主动 PEMF 设备或安慰剂设备,同时接受标准的术后疼痛管理。主要观察指标是在四个不同时间点使用视觉模拟量表测量的 12 小时累积术后疼痛强度。次要观察指标是术后 12 小时内通过 PCA 使用的 IV 芬太尼总量(mg)。该试验的主要分析比较了两组研究组报告的累积疼痛评分(静息和运动时)和术后 12 小时内 IV 芬太尼的累积使用量,使用 Wilcoxon 秩和检验。分析基于意向治疗原则进行。使用多重插补处理缺失数据,假设数据是随机缺失的。
结果:共有 118 名受试者被随机分配;58 名被分配到主动 PEMF 组,60 名被分配到安慰剂对照组。两组干预组的平均疼痛评分随时间推移呈相似趋势,在 12 小时的术后时间内下降。术后休息和运动时的 12 小时累积术后疼痛评分无显著差异。(W=1832.51933.0,p 值 0.61920.2985 用于休息时疼痛评分比较;W=1737.01804.5,p 值 0.98920.7296 用于运动时疼痛评分比较)。对于次要观察指标 12 小时芬太尼总用量,PEMF 与安慰剂组之间的比较在所有 20 个插补数据集之间也没有显示出统计学上的显著差异(W=1676.51859.0,p 值 0.73440.5234)。
讨论:PEMF 作为阑尾切除术后 12 小时内的辅助止痛治疗,并不优于安慰剂。以前在类似手术环境中报告的 PEMF 对术后疼痛强度和镇痛使用的影响无法得到证实。
试验注册:马来西亚国家医学研究登记处(NMRR-15-670-25,805)和泰国临床试验注册处(2019 年 11 月 1 日回顾性注册,研究 ID-TCTR20191102002)。
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