氢吗啡酮用于术后疼痛治疗；患者自控镇痛与靶控输注和标准患者自控镇痛的比较：一项随机对照试验。

Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial.

机构信息

From the Department of Anaesthesiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany (AW, HI, TF, MK, SK, AW, JS, CJ).

出版信息

Eur J Anaesthesiol. 2020 Dec;37(12):1168-1175. doi: 10.1097/EJA.0000000000001360.

DOI:10.1097/EJA.0000000000001360

PMID:33009192

Abstract

BACKGROUND

The challenge of managing acute postoperative pain is the well tolerated and effective administration of analgesics with a minimum of side effects. The standard therapeutic approach is patient-controlled analgesia (PCA) with systemic opioids. To overcome problems of oscillating opioid concentrations, we studied patient-controlled analgesia by target-controlled infusion (TCI-PCA) as an alternative.

OBJECTIVE

To compare efficacy, safety and side effects of standard PCA with TCI-PCA for postoperative pain therapy with hydromorphone.

DESIGN

Single-blinded, randomised trial.

SETTING

University Hospital, Germany from December 2013 to April 2015.

PARTICIPANTS

Fifty adults undergoing cardiac surgery.

INTERVENTIONS

Postoperative pain therapy on the ICU was managed with intravenous (i.v.) hydromorphone and patients randomised to TCI-PCA with target plasma concentrations between 0.8 and 10 ng ml, or PCA with bolus doses of 0.2 mg. Pain was regularly assessed using the 11-point numerical rating scale (NRS). Blood pressure, heart rate, oxygen saturation and cardiac output were continuously monitored, and adverse events were registered throughout the study.

MAIN OUTCOME MEASURES

NRS pain ratings, hydromorphone doses, haemodynamic effects and side effects.

RESULTS

NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA. The number of bolus doses during PCA was significantly higher than the number of target increases during TCI-PCA (P = 0.006). The number of negative requests was also significantly higher during PCA than during TCI-PCA (P = 0.02). The respiratory rate on the first postoperative morning was 25 ± 6 min during TCI-PCA, compared with 19 ± 4 min during PCA (P = 0.022). Nausea occurred in 30% after TCI-PCA and 24% after PCA (P = 0.46).

CONCLUSION

TCI-PCA was effective and well tolerated in acute postoperative pain management after cardiac surgery. Further studies are needed to evaluate this approach in clinical practice.

TRIAL REGISTRATION

EudraCT Number: 2013-002875-16, and ClinicalTrials.gov Identifier: NCT02035709.

摘要

背景

管理急性术后疼痛的挑战在于以最小的副作用实现镇痛药物的耐受和有效管理。标准的治疗方法是患者自控镇痛（PCA）加全身阿片类药物。为了克服阿片类药物浓度波动的问题，我们研究了以氢吗啡酮为目标的靶控输注（TCI-PCA）作为替代方法的患者自控镇痛。

目的

比较氢吗啡酮术后镇痛中标准 PCA 与 TCI-PCA 的疗效、安全性和副作用。

设计

单盲、随机试验。

地点

德国大学医院，2013 年 12 月至 2015 年 4 月。

参与者

50 名接受心脏手术的成年人。

干预措施

术后 ICU 采用静脉（iv）氢吗啡酮进行疼痛治疗，患者随机分为 TCI-PCA 组，目标血浆浓度为 0.8 至 10ng/ml，或 PCA 组，推注剂量为 0.2mg。使用 11 点数字评分量表（NRS）定期评估疼痛。连续监测血压、心率、血氧饱和度和心输出量，并在整个研究过程中记录不良事件。

主要观察指标

NRS 疼痛评分、氢吗啡酮剂量、血液动力学效应和副作用。

结果

TCI-PCA 和 PCA 之间的 NRS 疼痛评分、氢吗啡酮总剂量和血液动力学数据无显著差异。PCA 时推注剂量明显高于 TCI-PCA 时的目标增加剂量（P=0.006）。PCA 时的负请求数也明显高于 TCI-PCA 时（P=0.02）。TCI-PCA 时术后第一天早晨的呼吸频率为 25±6min，而 PCA 时为 19±4min（P=0.022）。TCI-PCA 后恶心发生率为 30%，PCA 后为 24%（P=0.46）。