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一项过渡性疼痛服务对术后发生慢性疼痛风险增加的手术患者的有效性(TRUSt研究)。一项随机临床试验。

The effectiveness of a transitional pain service in patients undergoing surgery with an increased risk of developing chronic postsurgical pain (TRUSt study). A randomized clinical trial.

作者信息

Admiraal Manouk, Hermanides Jeroen, Meinsma Soe L, Wartenberg Hans C H, Rutten Martin V H, Heine Yvonne, Kallewaard Jan Willem, Hollmann Markus W, Hermanns Henning

机构信息

Department of Anaesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Department of Anaesthesiology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; Department of Anaesthesiology, Rijnstate Hospital, Velp, the Netherlands.

出版信息

J Clin Anesth. 2023 Dec;91:111262. doi: 10.1016/j.jclinane.2023.111262. Epub 2023 Sep 16.

Abstract

STUDY OBJECTIVE

Poorly controlled acute postsurgical pain is associated with delayed recovery, chronic postsurgical pain (CPSP), chronic opioid use and impaired functioning in daily activities. The aim was to determine the effectiveness of a transitional pain service (TPS) to improve quality of recovery for patients at risk of CPSP. We hypothesized that a TPS improves the quality of recovery in patients at risk of CPSP.

DESIGN

Single-center, pragmatic, randomized, superiority trial.

SETTING

Tertiary hospital in the Netherlands.

PATIENTS

Assessed for eligibility if ≥18 years of age, undergoing elective surgery, and had an increased risk of developing CPSP. After being stratified for sex, 176 patients were included.

INTERVENTION

Patients were randomized to receive TPS or standard of care (SOC). TPS was a multidisciplinary intervention providing a patient-tailored perioperative pain management plan, throughout all phases of surgery.

MEASUREMENTS

The primary outcome was the difference in quality of recovery on the third postoperative day, measured by the Quality of Recovery (QoR)-15 questionnaire. Secondary outcomes include the between group differences in opioid consumption.

MAIN RESULTS

The primary outcome was available in 169 (96.0%) patients. No difference between groups was found in QoR-15 on the third postoperative day (mean difference 2.0, 95% CI -5.5 to 9.4, p = 0.607). A decrease in opioid usage (compared to baseline) was observed in chronic opioid users, the median [IQR] reduction in total daily oral morphine milligram equivalents (MME) for TPS was -30 [-60, 0] at three and - 29.3 [-65.6, 0] at six months, whereas SOC had a median reduction of 0 [-56, 0] at three, and 0 [-60, 7.5] at six months.

CONCLUSIONS

TPS did not significantly affect short-term quality of recovery but might improve long-term outcomes, such as the incidence of chronic pain, opioid consumption, and functioning in daily life. However, sample size in the present study was too small to provide solid evidence for this positive signal.

摘要

研究目的

术后急性疼痛控制不佳与恢复延迟、慢性术后疼痛(CPSP)、长期使用阿片类药物以及日常生活功能受损有关。本研究旨在确定过渡性疼痛服务(TPS)对改善有CPSP风险患者恢复质量的有效性。我们假设TPS能提高有CPSP风险患者的恢复质量。

设计

单中心、实用、随机、优效性试验。

地点

荷兰的一家三级医院。

患者

年龄≥18岁、接受择期手术且有发生CPSP风险增加的患者接受资格评估。按性别分层后,纳入了176例患者。

干预措施

患者被随机分为接受TPS或标准治疗(SOC)。TPS是一种多学科干预措施,在手术的所有阶段提供针对患者的围手术期疼痛管理计划。

测量指标

主要结局是术后第三天的恢复质量差异,通过恢复质量(QoR)-15问卷进行测量。次要结局包括两组之间阿片类药物消耗量的差异。

主要结果

169例(96.0%)患者获得了主要结局数据。术后第三天,两组在QoR-15方面未发现差异(平均差异2.0,95%置信区间-5.5至9.4,p = 0.607)。长期使用阿片类药物的患者阿片类药物使用量(与基线相比)有所减少,TPS组在术后三个月和六个月时,每日口服吗啡毫克当量(MME)总量的中位数[四分位间距]减少分别为-30[-60, 0]和-29.3[-65.6, 0],而SOC组在术后三个月和六个月时的中位数减少分别为0[-56, 0]和0[-60, 7.5]。

结论

TPS对短期恢复质量没有显著影响,但可能改善长期结局,如慢性疼痛的发生率、阿片类药物消耗量和日常生活功能。然而,本研究的样本量过小,无法为这一积极信号提供确凿证据。

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