Federative Centre of Pelvi-Perineology, CHU Nantes, Nantes, France.
Pain Unit, Centre Catherine de Sienne, Nantes, France.
BJOG. 2017 Jan;124(2):251-260. doi: 10.1111/1471-0528.14222. Epub 2016 Jul 27.
To compare the effect of corticosteroids combined with local anaesthetic versus local anaesthetic alone during infiltrations of the pudendal nerve for pudendal nerve entrapment.
Randomised, double-blind, controlled trial.
Multicentre study.
201 patients were included in the study, with a subgroup of 122 women.
CT-guided pudendal nerve infiltrations were performed in the sacrospinous ligament and Alcock's canal. There were three study arms: patients in Arm A (n = 68) had local anaesthetic alone, those in Arm B (n = 66) had local anaesthetic plus corticosteroid and those in Arm C (n = 67) local anaesthetic plus corticosteroid with a large volume of normal saline.
The primary end-point was the pain intensity score at 3 months. Patients were regarded as responders (at least a 30-point improvement on a 100-point visual analogue scale of mean maximum pain over a 2-week period) or nonresponders.
Three months' postinfiltration, 11.8% of patients in the local anaesthetic only arm (Arm A) were responders versus 14.3% in the local anaesthetic plus corticosteroid arms (Arms B and C). This difference was not statistically significant (P = 0.62). No statistically significant difference was observed in the female subgroup between Arm A and Arms B and C (P = 0.09). No significant difference was detected for the various pain assessment procedures, functional criteria or quality-of-life criteria.
Corticosteroids provide no additional therapeutic benefits compared with local anaesthetic and should therefore no longer be used.
Steroid infiltrations do not improve the results of local anaesthetic infiltrations in pudendal neuralgia.
比较阴部神经阻滞时皮质类固醇联合局部麻醉与单纯局部麻醉的效果。
随机、双盲、对照试验。
多中心研究。
共有 201 名患者入组研究,其中包括 122 名女性亚组。
在骶棘韧带和 Alcock 管行 CT 引导阴部神经阻滞。共有 3 个研究组:A 组(n=68)仅给予局部麻醉,B 组(n=66)给予局部麻醉+皮质类固醇,C 组(n=67)给予局部麻醉+皮质类固醇+大体积生理盐水。
主要终点为 3 个月时的疼痛强度评分。患者被认为是有反应者(在 2 周内平均最大疼痛的 100 点视觉模拟量表上至少改善 30 分)或无反应者。
在阴部神经阻滞后 3 个月,局部麻醉组(A 组)有 11.8%的患者为有反应者,而局部麻醉+皮质类固醇组(B 组和 C 组)有 14.3%的患者为有反应者。差异无统计学意义(P=0.62)。在女性亚组中,A 组与 B 组和 C 组之间无统计学差异(P=0.09)。在各种疼痛评估程序、功能标准或生活质量标准方面均未发现显著差异。
与局部麻醉相比,皮质类固醇并不能提供额外的治疗益处,因此不应再使用。
皮质类固醇注射并不能改善阴部神经痛患者局部麻醉注射的效果。