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脊髓麻醉时侧卧位方向与股骨颈骨折患者定位疼痛之间的关系:随机非劣效性试验。

The relationship between the orientation of the lateral decubitus position for spinal anesthesia and positioning pain in patients with a femoral neck fracture: randomized non-inferiority trial.

作者信息

Yoshida Keisuke, Hareyama Itaru, Noji Yoshie, Tanaka Shiori, Watanabe Kazuhiro, Inoue Satoki

机构信息

Department of Anesthesiology, Aidu Chuo Hospital, 1-1, Tsuruga-machi, Aizuwakmatsu, Fukushima, 965-8611, Japan.

Department of Anesthesiology, Fukushima Medical University, 1, Hikariga-oka, Fukushima, 960-1297, Japan.

出版信息

JA Clin Rep. 2023 Jan 27;9(1):3. doi: 10.1186/s40981-023-00595-y.

Abstract

BACKGROUND

To date, no clinical studies have investigated the relationship between positioning pain and orientation of the lateral decubitus position for hip fracture surgery. The aim of the present study was to test the hypothesis that performing spinal anesthesia in the lateral decubitus position with the fracture side up or down does not affect positioning pain in patients with a femoral neck fracture.

METHODS

This single-center, prospective, randomized non-inferiority trial examined 78 patients who received surgery for a femoral neck fracture under spinal anesthesia. By performing spinal anesthesia in the left lateral decubitus position in all patients, the positioning of the fracture up or down was randomized. Pain score during spinal anesthesia was evaluated objectively (0, calm; 1, facial grimacing; 2, moaning; 3, screaming; or 4, unable to proceed because of restlessness or agitation).

RESULTS

The data from 66 patients (fracture side down [n = 35] and up [n = 31]) were analyzed. There were no significant differences between the fracture side down and fracture side up groups regarding the percentage of patients who were assessed to have intense pain (score ≥ 3) when changing position from the supine to lateral position (13/35 [37%] vs 12/31 [39%]; 95% confidence interval [95% CI] for the difference of the percentage of patients of intense pain between the groups - 25.0 to 2.2; p = 1.000).

CONCLUSIONS

There were no significant differences in the percentage of patients experiencing severe pain between the two groups. The 95% CI exceeded the preliminarily set a margin of inferiority of 20%; thus, the present study could not demonstrate the non-inferiority of the fractured side down group in terms of pain score.

摘要

背景

迄今为止,尚无临床研究调查髋关节骨折手术侧卧位的体位疼痛与方向之间的关系。本研究的目的是检验以下假设:在股骨颈骨折患者中,骨折侧朝上或朝下进行侧卧位脊麻不会影响体位疼痛。

方法

这项单中心、前瞻性、随机非劣效性试验研究了78例在脊麻下接受股骨颈骨折手术的患者。通过让所有患者在左侧卧位进行脊麻,随机确定骨折侧朝上或朝下的体位。客观评估脊麻期间的疼痛评分(0分,平静;1分,面部 grimacing;2分,呻吟;3分,尖叫;或4分,因烦躁不安或激动而无法继续)。

结果

分析了66例患者(骨折侧朝下[n = 35]和朝上[n = 31])的数据。在从仰卧位变为侧卧位时,骨折侧朝下组和骨折侧朝上组在被评估为有剧烈疼痛(评分≥3)的患者百分比方面无显著差异(13/35 [37%] 对12/31 [39%];两组间剧烈疼痛患者百分比差异的95%置信区间[95%CI]为 - 25.0至2.2;p = 1.000)。

结论

两组间经历严重疼痛的患者百分比无显著差异。95%CI超过了预先设定的20%的非劣效性 margin;因此,本研究无法证明骨折侧朝下组在疼痛评分方面的非劣效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c574/9880088/5f026e67cbd8/40981_2023_595_Fig1_HTML.jpg

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