Al-Ameri Laith Thamer, Shukri Mohammed Emad, Hameed Ekhlas Khalid, Marzook Ahmed Abed
Al-Kindy College of Medicine, University of Baghdad, Baghdad, Iraq.
Dijlah University College, Baghdad, Iraq.
J Korean Neurosurg Soc. 2024 Mar;67(2):202-208. doi: 10.3340/jkns.2022.0225. Epub 2023 Sep 15.
Failed back surgery syndrome (FBSS) is a common long-term complication following spine surgeries characterized by chronic persistent pain; different strategies of management were employed to deal with it. This clinical trial aims to compare the efficacy of Pregabalin and Gabapentin in the management of this condition.
A double-blind, randomized, comparative study (clinical trial registry NCT05324761 on 11th April 2022) with two parallel arms with Pregabalin and Gabapentin were used in arms one and two, respectively. Visual analog scale was used for basal and endpoint assessment of pain. T-test and analysis of covariance were used to deal with different variables. A pairwise test was used to compare pairs of means.
Of 66 patients referred to the trial, 64 were eligible, with 60 patients completing the 30 days trial. Both pregabalin and gabapentin effectively reduce pain, with significant p-values of 0.001 for each group. However, the pregabalin group was superior to gabapentin in pain reduction (p=0.001). Gender was an insignificant factor (p=0.574 and p=0.445 for the pregabalin and gabapentin groups, respectively, with a non-significant reduction (p=0.393) for both groups in total. Location of stenosis before surgery and type of surgery performed show non-significant effect on pain reduction for both groups.
Both pregabalin and gabapentin effectively and safely relieve neuropathic pain associated with FBSS; pregabalin was significantly more effective irrespective of the patients' gender.
腰椎手术失败综合征(FBSS)是脊柱手术后常见的长期并发症,其特征为慢性持续性疼痛;人们采用了不同的治疗策略来应对这一情况。本临床试验旨在比较普瑞巴林和加巴喷丁治疗该病症的疗效。
一项双盲、随机、对照研究(2022年4月11日临床试验注册编号NCT05324761),两个平行组分别使用普瑞巴林和加巴喷丁。采用视觉模拟量表对疼痛进行基线和终点评估。使用t检验和协方差分析处理不同变量。采用两两检验比较均值对。
在纳入该试验的66例患者中,64例符合条件,60例患者完成了30天的试验。普瑞巴林和加巴喷丁均能有效减轻疼痛,每组的p值均为0.001,具有显著性。然而,普瑞巴林组在减轻疼痛方面优于加巴喷丁组(p = 0.001)。性别是一个不显著的因素(普瑞巴林组和加巴喷丁组的p值分别为0.574和0.445,两组总体减轻程度均无显著性差异(p = 0.393))。术前狭窄部位和所施行手术的类型对两组减轻疼痛的效果均无显著影响。
普瑞巴林和加巴喷丁均能有效且安全地缓解与FBSS相关的神经性疼痛;无论患者性别如何,普瑞巴林的疗效均显著更佳。