Raak Christa K, Ostermann Thomas, Schönenberg-Tu Anna-Li, Fricke Oliver, Martin David D, Robens Sibylle, Scharbrodt Wolfram
Institute of Integrative Medicine, Witten/Herdecke University, 58313 Herdecke, Germany.
Integrative Neuromedicine, Community Hospital Herdecke, Witten/Herdecke University, 58313 Herdecke, Germany.
J Clin Med. 2022 Apr 22;11(9):2333. doi: 10.3390/jcm11092333.
Gender issues have received increasing attention in clinical research of the past years, and biological sex has been introduced as a moderating variable in experimental pain perception. However, in clinical studies of acute pain and gender, there are conflicting results. In particular, there are limited data on the impact of gender differences after spinal sequestrectomy. The aim of this work is to examine gender differences in postoperative pain and pain medication consumption in an inpatient clinical setting.
Data of a completed double-blind RCT was subdivided by gender and reanalyzed by means of an analysis of variance in repeated measures. Outcomes included pain severity measured on a VAS, affective (SES-A) and sensory pain perception (SES-S) and morphine equivalent doses (MED) of analgesics after spinal sequestrectomy.
In total, 42 female (47.73%) and 46 male (52.27%) patients were analyzed. No differences in pain severity (VAS: Gender × Time F = 0.35; (df = 2, 86); = 0.708), affective and sensory pain perception (SES-A: Gender × Time F = 0.08; (df = 2, 86); = 0.919; SES-S: Gender × Time F = 0.06; (df = 2, 86); = 0.939) or post-operative opioid use between men and women (MEDs: Gender × Time F = 1.44; (df = 2, 86); = 0.227) could be observed.
This reanalysis of an RCT with respect to gender differences is to our knowledge the first attempt to investigate the role of gender in pain perception and medication after lumbar spine sequestrectomy. In contrast to other studies, we were not able to show significant differences between male and female patients in all pain-related outcomes. Apart from well-established pain management, psychological reasons such as gender-specific response biases or the observer effect might explain our results.
The study was registered as a regulatory phase IV study at the German Clinical Trials Register (DRKS), an open-access online register for clinical trials conducted in Germany (Reg-No: DRKS00007913).
在过去几年的临床研究中,性别问题受到了越来越多的关注,生物性别已被引入作为实验性疼痛感知的调节变量。然而,在急性疼痛与性别的临床研究中,结果存在冲突。特别是,关于脊柱后纵韧带骨化症手术后性别差异影响的数据有限。这项工作的目的是在住院临床环境中研究术后疼痛和止痛药消费的性别差异。
一项已完成的双盲随机对照试验的数据按性别进行细分,并通过重复测量方差分析进行重新分析。结果包括脊柱后纵韧带骨化症手术后用视觉模拟评分法测量的疼痛严重程度、情感性(SES-A)和感觉性疼痛感知(SES-S)以及镇痛药的吗啡等效剂量(MED)。
总共分析了42名女性(47.73%)和46名男性(52.27%)患者。在疼痛严重程度(视觉模拟评分法:性别×时间F = 0.35;(自由度 = 2, 86);P = 0.708)、情感性和感觉性疼痛感知(SES-A:性别×时间F = 0.08;(自由度 = 2, 86);P = 0.919;SES-S:性别×时间F = 0.06;(自由度 = 2, 86);P = 0.939)或男女之间术后阿片类药物使用情况(吗啡等效剂量:性别×时间F = 1.44;(自由度 = 2, 86);P = 0.227)方面未观察到差异。
据我们所知,这项关于性别差异的随机对照试验重新分析是首次尝试研究性别在腰椎后纵韧带骨化症手术后疼痛感知和用药中的作用。与其他研究不同,我们未能在所有疼痛相关结果中显示出男性和女性患者之间的显著差异。除了既定的疼痛管理外,诸如性别特异性反应偏差或观察者效应等心理因素可能解释我们的结果。
该研究在德国临床试验注册中心(DRKS)注册为IV期监管研究,DRKS是德国进行临床试验的开放获取在线注册库(注册号:DRKS00007913)。