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临床试验/NCT04480281
NCT04480281已完成4 期

Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pain scores at rest and at cough

研究概览

简要总结

Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in colorectal surgery.

However, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. The present study aims to evaluate the influence of IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery

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
Double (Participant, Care Provider)

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

  • American society of anesthesiologists (ASA) scores of I, II or III.
  • Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).

排除标准

  • patient's refusal to participate
  • ASA score of IV or higher
  • severe hepatic or renal insufficiency
  • allergy to lidocaine, morphine or NSAIDs
  • cardiac arrhythmias or
  • epilepsy,
  • delayed extubation for more than 2 h postoperatively
  • urgent surgery

研究组 & 干预措施

Placebo Group

Placebo Comparator

Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively

干预措施: Normal Saline (Drug)

Lidocaine Group

Active Comparator

Bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery

干预措施: Lidocaine Iv (Drug)

结局指标

主要结局

Pain scores at rest and at cough

时间窗: Measurements were made for 24 hours in the post operative period

Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough

Opioid consumption in the post operative period

时间窗: Doses were measured for twenty four hours in the post operative period

Total dose of morphine in the post operative period is measured for patients in both arms

次要结局

  • Pulmonary complications(Measurements were recorded for 24 hours in the post operative period)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Afrida Gergess

Anesthesiologist specialized in cardiovascular and thoracic surgery

Saint-Joseph University

研究点 (1)

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