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临床试验/NCT03666299
NCT03666299Unknown不适用

Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)

Guangzhou First People's Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年11月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
Occurrence of chronic pain

研究概览

简要总结

This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery

详细描述

Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases

排除标准

  • (1)ASA classification status III or above
  • (2)Body weight<35kg
  • (3)Liver cirrhosis
  • (4)A history of previous thoracotomy
  • (5)Pregnancy
  • (6)Severe arrhythmia
  • (7)Congestive heart failure
  • (8)Opioid or steroid use 6 months before surgery
  • (9)Allergy to lidocaine
  • (10)Chronic pain syndrome (any type)
  • (11)Emergency surgery
  • (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders

研究组 & 干预措施

Lidocaine

Experimental

Lidocaine treatment

干预措施: Lidocaine (Drug)

Control

Placebo Comparator

Placebo treatment

干预措施: Control (Drug)

结局指标

主要结局

Occurrence of chronic pain

时间窗: At 3 months after surgery.

Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.

次要结局

  • Postoperative acute pain(postoperative days 1 and 2.)
  • Sedation(postoperative days 1 and 2.)
  • Postoperative nausea and vomiting (PONV) nausea(postoperative days 1 and 2.)
  • Fatigue(postoperative days 1 and 2.)
  • Occurrence of chronic pain at 6-month(At 6 months after surgery.)

研究者

发起方
Guangzhou First People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Professor

Guangzhou First People's Hospital

研究点 (1)

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