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病理性疼痛：一项随机、安慰剂对照、双盲研究

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

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病理性疼痛：一项随机、安慰剂对照、双盲研究 

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.We performed a long-term (1-year) follow-up to evaluate the effects of intraoperative iv infusion of dexmedetomidine and lidocaine on the occurrence of chronic pain after abdominal gynecological surgery. The study endpoints were the development of CPP with or without neuropathic elements at 3, 6, and 12 months postoperatively. We also identified possible risk factors for the transition of acute postoperative pain to CPP.

引言：急性到慢性术后疼痛（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很有前途的药物。为此，作者进行了一项长期（1年）随访，以评估术中静脉输注右美托咪定和利多卡因对妇科腹部手术后慢性疼痛发生的影响。研究终点是术后3个月、6个月和12个月有无神经病变因素的CPP发展。本研究还确定了急性术后疼痛转变为CPP的可能风险因素。 

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 lg/kg dexmedetomidine or 1.5 mg/kg lidocaine or placebo, followed by 0.6 lg/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.

方法：这是一项随机、安慰剂对照、双盲研究的长期随访，研究对象为接受妇科开腹手术并在围手术期接受右美托咪定、利多卡因或安慰剂输注的女性（n=81）。在12个月的随访期间，评估了这些佐剂对CPP和神经病理性疼痛发展的影响。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）或安慰剂（CONTROL）。在麻醉诱导前，所有患者接受0.6 lg/kg右美托咪定或1.5 mg/kg利多卡因或安慰剂的负荷静脉注射剂量，然后是0.6 lg/kg/h右美托咪定或1.5 mg/kg/h利多卡因或安慰剂，直到最后一次缝合。对患者进行随访，以获得3个月、6个月和12个月的长期结果。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Douleur Neurophique 4（DN4）评分评估神经病变因素的发展。还确定了可能影响慢性疼痛及其组成部分的预后参数。 

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.We performed a long-term (1-year) follow-up to evaluate the effects of intraoperative iv infusion of dexmedetomidine and lidocaine on the occurrence of chronic pain after abdominal gynecological surgery. The study endpoints were the development of CPP with or without neuropathic elements at 3, 6, and 12 months postoperatively. We also identified possible risk factors for the transition of acute postoperative pain to CPP.

引言：急性到慢性术后疼痛（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很有前途的药物。为此，作者进行了一项长期（1年）随访，以评估术中静脉输注右美托咪定和利多卡因对妇科腹部手术后慢性疼痛发生的影响。研究终点是术后3个月、6个月和12个月有无神经病变因素的CPP发展。本研究还确定了急性术后疼痛转变为CPP的可能风险因素。 

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).

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，利多卡因在预防神经病理性疼痛方面优于安慰剂（p=0.02），但不优于右美托咪定（DN4<4）。关于次要终点，48小时时NRS咳嗽评分较高与3个月、6个月和12个月时NRS和DN4评分具有统计学显著性相关（p<0.02）。6个月时，NRS值越高，年龄越大（p=0.020），两者之间也存在显著的统计学相关性。

主要结果

三个研究组（DEX组：右美托咪定，LIDO：利多卡因，CONTROL：生理盐水）48小时的NRS咳嗽（NRS，数字评分量表0-10）以及每个干预组三个时间点的NRS评分。3个月时，与对照组相比，DEX组的疼痛评分在统计学上显著降低（p=0.018）。各组在3个月、6个月和12个月时的疼痛评分无其他统计学差异。

各治疗组在三个时间点的DN4得分如表6所示。尽管与其他两组相比，对照组在所有时期的得分似乎都更高（图2），但这些差异没有统计学意义（p>0.05）.

logistic回归模型还显示，根据治疗组的不同，神经病理性疼痛在统计学上存在显著差异（p=0.048）。在利多卡因（0%）组和对照组（20%）之间观察到了这种差异（p=0.02），但在其他组之间没有观察到这种差异[DEX（4.2%）与对照组（p=0.106）以及DEX与利多卡因（p=0.442）]。

分析表明，48小时咳嗽NRS评分对DN4评分在三个时间段（即3个月、6个月和12个月）均有统计学显著影响，p值分别为0.01、0.01和0.01。因此，所有时间段的DN4值越高，48小时NRS咳嗽评分值越高，如表8所示。   

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