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围手术期输注右美托咪定或利多卡因预防妇科手术后慢性术后疼痛和神经性疼痛:一项随机、安慰剂对照、双盲研究

Perioperative Dexmedetomidine or Lidocaine Infusion for the Prevention of Chronic Postoperative and Neuropathic Pain After Gynecological Surgery: A Randomized, Placebo-Controlled, Double-Blind Study.

作者信息

Rekatsina Martina, Theodosopoulou Polyxeni, Staikou Chryssoula

机构信息

Basildon University Hospital, Mid and South Essex NHS Foundation Trust, London, UK.

Aretaieion Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Pain Ther. 2022 Jun;11(2):529-543. doi: 10.1007/s40122-022-00361-5. Epub 2022 Feb 15.

Abstract

INTRODUCTION

The transition of acute to chronic postoperative pain (CPP) remains a significant burden to the rehabilitation of patients. The research for adjuvants to prevent CPP continues; among others, dexmedetomidine and lidocaine seem promising agents.

METHODS

This is a long-term follow-up of a randomized, placebo-controlled, double-blind study on women who underwent open abdominal gynecological surgery and received dexmedetomidine or lidocaine or placebo infusion perioperatively (n = 81). The effect of these adjuvants on the development of CPP and neuropathic pain was assessed during a 12-month follow-up. Eighty-one (81) women ASA I-II, aged between 30 and 70 years, were randomly assigned to receive either dexmedetomidine (DEX group) or lidocaine (LIDO group) or placebo (CONTROL group) perioperatively. Before anesthesia induction, all patients received a loading intravenous dose of either 0.6 μg/kg dexmedetomidine or 1.5 mg/kg lidocaine or placebo, followed by 0.6 μg/kg/h dexmedetomidine or 1.5 mg/kg/h lidocaine or placebo until last suture. Patients were followed up to obtain the long-term outcomes at 3, 6, and 12 months. At these time-points, pain intensity was assessed with the Numerical Rating Scale, (NRS: 0-10) and the development of neuropathic elements with the Douleur Neuropathique 4 (DN4) score. Prognostic parameters that could affect chronic pain and its components were also identified.

RESULTS

Data from 74 women were analyzed. Dexmedetomidine significantly reduced NRS scores comparing to placebo at 3 months (p = 0.018), while at 6 months, lidocaine was found superior to placebo (p = 0.02), but not to dexmedetomidine, in preventing neuropathic pain (DN4 < 4). Regarding secondary endpoints, higher NRS cough scores at 48 h were associated with statistically significant NRS and DN4 scores at 3, 6, and 12 months (p < 0.02). At 6 months, a statistically significant correlation was also found between higher NRS values and older age (p = 0.020).

CONCLUSIONS

Dexmedetomidine was superior to placebo regarding the duration and severity of CPP, while lidocaine exhibited a protective effect against neuropathic elements of CPP.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT03363425.

摘要

引言

急性术后疼痛向慢性术后疼痛(CPP)的转变仍然是患者康复的重大负担。预防CPP的佐剂研究仍在继续;其中,右美托咪定和利多卡因似乎是有前景的药物。

方法

这是一项对接受开放性腹部妇科手术且围手术期接受右美托咪定或利多卡因或安慰剂输注的女性进行的随机、安慰剂对照、双盲研究的长期随访(n = 81)。在12个月的随访期间评估这些佐剂对CPP和神经性疼痛发展的影响。81名年龄在30至70岁之间的ASA I-II级女性被随机分配在围手术期接受右美托咪定(DEX组)或利多卡因(LIDO组)或安慰剂(对照组)。在麻醉诱导前,所有患者静脉注射负荷剂量的0.6μg/kg右美托咪定或1.5mg/kg利多卡因或安慰剂,随后以0.6μg/kg/h右美托咪定或1.5mg/kg/h利多卡因或安慰剂持续输注直至最后一针缝合。对患者进行随访以获取3个月、6个月和12个月时的长期结果。在这些时间点,使用数字评分量表(NRS:0-10)评估疼痛强度,并使用神经病理性疼痛4(DN4)评分评估神经病理性因素的发展。还确定了可能影响慢性疼痛及其组成部分的预后参数。

结果

分析了74名女性的数据。与安慰剂相比,右美托咪定在3个月时显著降低了NRS评分(p = 0.018),而在6个月时,在预防神经性疼痛(DN4 < 4)方面,利多卡因优于安慰剂(p = 0.02),但不优于右美托咪定。关于次要终点,48小时时较高的NRS咳嗽评分与3个月、6个月和12个月时具有统计学意义的NRS和DN4评分相关(p < 0.02)。在6个月时,还发现较高的NRS值与年龄较大之间存在统计学意义的相关性(p = 0.020)。

结论

在CPP的持续时间和严重程度方面,右美托咪定优于安慰剂,而利多卡因对CPP的神经病理性因素具有保护作用。

试验注册

ClinicalTrials.gov标识符,NCT03363425。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/294b/9098708/1f5cb00aab22/40122_2022_361_Fig1_HTML.jpg

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