Is perioperative use of a combination of pregabalin and naproxen superior to naproxen only in reducing pain in ankle fractures? A prospective, randomized, multicenter study.

IF 2.8 3区 医学 Q1 ORTHOPEDICS
Gi Won Choi, Kwang Hwan Park, Yeo Kwon Yoon, Jin Woo Lee, Dong Woo Shim
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Abstract

Purpose: To compare the analgesic efficacy, adverse effects, and long-term functional outcomes of perioperative naproxen alone versus naproxen with pregabalin for treating pain in ankle fractures.

Methods: This study included 70 patients who underwent operative fixation of rotatory ankle fractures. Group A received naproxen 500 mg only, and Group B received naproxen 500 mg with pregabalin 75 mg 2-hour before surgery and 12 hourly for 14 days thereafter. The minimal clinically important difference of the visual analog scale (VAS) for pain was set at 1.8 out of 10. VAS for pain, opioid consumption, and any adverse effects were recorded for 3 days postoperatively. VAS for pain was checked at 2- and 6-weeks and 3- and 6-months, and functional outcomes were measured at 3- and 6-months postoperatively.

Results: Sixty-three patients (33 and 30 in groups A and B, respectively) completed the 6-month follow-up. Demographic data were similar between groups. VAS for pain did not significantly differ between the groups at any timepoint up to 6 months (P ≥ 0.520), with 95% confidence intervals consistently within 1.8. No significant differences were observed between groups in opioid consumption and functional outcomes (P ≥ 0.211). In group B, dizziness at 48-hour and somnolence at 72-hour were significantly predominant (P ≤ 0.05).

Conclusion: Our study demonstrated comparable pain reduction between two groups following operative fixation of rotatory ankle fractures. However, side effects, including dizziness and somnolence, were predominant in Group B between 48 and 72 h.

围手术期普瑞巴林联合萘普生在减轻踝关节骨折疼痛方面是否优于萘普生?一项前瞻性、随机、多中心研究。
目的:比较萘普生单用与萘普生联合普瑞巴林治疗踝关节骨折疼痛围手术期的镇痛效果、不良反应和远期功能结局。方法:本研究纳入70例踝关节旋转骨折的手术固定。A组仅给予萘普生500 mg, B组术前2小时、术后14天每12小时给予萘普生500 mg加普瑞巴林75 mg。视觉模拟评分(VAS)对疼痛的最小临床重要差异设定为1.8分(满分10分)。术后3天记录疼痛、阿片类药物消耗和任何不良反应的VAS评分。分别在术后2周、6周、3月和6个月检查疼痛的VAS评分,在术后3月和6个月测量功能结果。结果:63例患者(A组33例,B组30例)完成了6个月的随访。两组之间的人口统计数据相似。6个月前各组间疼痛VAS评分无显著差异(P≥0.520),95%置信区间一致在1.8以内。各组间阿片类药物消费和功能结局无显著差异(P≥0.211)。B组48小时头晕、72小时嗜睡明显占优势(P≤0.05)。结论:我们的研究表明,两组在踝关节旋转骨折手术固定后疼痛减轻程度相当。然而,副作用,包括头晕和嗜睡,在B组在48至72小时内主要存在。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.10
自引率
7.70%
发文量
494
审稿时长
>12 weeks
期刊介绍: Journal of Orthopaedic Surgery and Research is an open access journal that encompasses all aspects of clinical and basic research studies related to musculoskeletal issues. Orthopaedic research is conducted at clinical and basic science levels. With the advancement of new technologies and the increasing expectation and demand from doctors and patients, we are witnessing an enormous growth in clinical orthopaedic research, particularly in the fields of traumatology, spinal surgery, joint replacement, sports medicine, musculoskeletal tumour management, hand microsurgery, foot and ankle surgery, paediatric orthopaedic, and orthopaedic rehabilitation. The involvement of basic science ranges from molecular, cellular, structural and functional perspectives to tissue engineering, gait analysis, automation and robotic surgery. Implant and biomaterial designs are new disciplines that complement clinical applications. JOSR encourages the publication of multidisciplinary research with collaboration amongst clinicians and scientists from different disciplines, which will be the trend in the coming decades.
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