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多模式非阿片类疼痛方案在半月板手术后与阿片类药物控制的疼痛效果相当:一项前瞻性随机对照试验。

Multimodal Nonopioid Pain Protocol Provides Equivalent Pain Versus Opioid Control Following Meniscus Surgery: A Prospective Randomized Controlled Trial.

机构信息

Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, U.S.A..

Department of Orthopedic Surgery, Mayo Clinic, Minneapolis, Minnesota, U.S.A.

出版信息

Arthroscopy. 2021 Jul;37(7):2237-2245. doi: 10.1016/j.arthro.2021.02.043. Epub 2021 Mar 10.

DOI:10.1016/j.arthro.2021.02.043
PMID:33713756
Abstract

PURPOSE

To assess the effectiveness of a nonopioid pain regimen in controlling postoperative pain as compared with a traditional opioid pain control following primary meniscectomy or meniscal repair.

METHODS

Ninety-nine patients undergoing primary meniscectomy or meniscal repair were assessed for participation. A prospective randomized control trial was performed in accordance with the Consolidated Standards of Reporting Trials 2010 statement. The 2 arms of the study included a multimodal nonopioid analgesic protocol and a standard opioid regimen with a primary outcome of postoperative pain level (visual analog scale) for the first 10 days postoperatively. Secondary outcomes included patient-reported outcomes, complications, and patient satisfaction. Randomization was achieved using a random-number generator. Patients were not blinded. Data collection was done by a blinded observer.

RESULTS

Eleven patients did not meet the inclusion criteria, and 27 declined participation. A total of 61 patients were analyzed with 30 randomized to the opioid regimen and 31 randomized to the nonopioid regimen. Patients receiving the nonopioid regimen demonstrated noninferior visual analog scale scores compared with patients who received opioid pain medication (P > .05). No significant differences were found in preoperative (opioid: 58.9 ± 7.0; nonopioid: 58.2 ± 5.5, P = .724) or postoperative (opioid: 59.8 ± 6.5; nonopioid: 54.9 ± 7.1, P = .064) Patient-Reported Outcomes Measurement and Information System Pain Interference Short Form scores. No difference was found in recorded side effects between both groups at any given time point: constipation, nausea, diarrhea, upset stomach, and drowsiness (P > .05).

CONCLUSIONS

This study found that a multimodal nonopioid pain protocol provided equivalent pain control and patient outcomes following primary meniscus surgery while having an equivalent side effect profile. All patients reported satisfaction with their pain management without requiring emergency opioid analgesia.

LEVEL OF EVIDENCE

Level I, prospective randomized controlled trial.

摘要

目的

评估非阿片类疼痛方案在控制原发性半月板切除术或半月板修复术后疼痛方面的有效性,与传统阿片类药物疼痛控制相比。

方法

对 99 例接受原发性半月板切除术或半月板修复术的患者进行了参与评估。按照 2010 年 CONSORT 声明进行了前瞻性随机对照试验。该研究的 2 个组包括多模式非阿片类镇痛方案和标准阿片类药物方案,主要结局为术后 10 天内的术后疼痛水平(视觉模拟评分)。次要结局包括患者报告的结果、并发症和患者满意度。采用随机数发生器实现随机分组。患者未设盲,数据采集由设盲观察者进行。

结果

11 例患者不符合纳入标准,27 例患者拒绝参与。共有 61 例患者进行了分析,其中 30 例随机分配到阿片类药物组,31 例随机分配到非阿片类药物组。接受非阿片类药物治疗的患者与接受阿片类药物治疗的患者相比,视觉模拟评分无显著差异(P >.05)。术前(阿片类药物:58.9 ± 7.0;非阿片类药物:58.2 ± 5.5,P =.724)或术后(阿片类药物:59.8 ± 6.5;非阿片类药物:54.9 ± 7.1,P =.064)患者报告的测量和信息系统疼痛干扰简表评分无显著差异。在任何给定时间点,两组之间记录的副作用均无差异:便秘、恶心、腹泻、胃部不适和嗜睡(P >.05)。

结论

本研究发现,多模式非阿片类疼痛方案在原发性半月板手术后提供了等效的疼痛控制和患者结局,同时具有等效的副作用特征。所有患者均报告对其疼痛管理满意,无需紧急阿片类药物镇痛。

证据水平

I 级,前瞻性随机对照试验。

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