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临床试验/NCT01277835
NCT01277835已完成不适用

Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
PCA Morphine Consumption

研究概览

简要总结

The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.

详细描述

Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • Age 18-75
  • Scheduled for VATS procedure

排除标准

  • Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery
  • Patients on preoperative analgesic therapy within one week of surgery
  • Patients with history of drug or alcohol abuse
  • Patients who are allergic to lidocaine
  • Contraindication to self administered morphine (unable to understand the PCA)
  • Progression of the procedure to thoracotomy
  • Patients who need postoperative mechanical ventilation
  • Necessary major deviation from the intraoperative study protocol as per the discretion of the anesthesiologist in charge of the case
  • Patients who are breastfeeding or pregnant
  • Patient refusal

研究组 & 干预措施

Placebo

Placebo Comparator

Saline Infusion

干预措施: Placebo (Drug)

Lidocaine Infusion

Experimental

干预措施: Lidocaine Infusion (Drug)

结局指标

主要结局

PCA Morphine Consumption

时间窗: Up to 48hrs post-initiation of patient-controlled analgesia

Patient-controlled analgesia machines will be reviewed for the total morphine doses administered at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

Verbal Rating Scale for pain at rest

时间窗: Up to 48hrs post-initiation of patient-controlled analgesia

Patients will be questioned about pain intensities at rest using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

Number of PCA Morphine Requests

时间窗: Up to 48hrs post-initiation of patient-controlled analgesia

PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.

Verbal Rating Scale for pain with deep inspiration

时间窗: Up to 48 hrs post-initiation of patient-controlled analgesia

Patients will be questioned about pain intensities with a deep inspiratory breath using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, and 48 hours post-initiaition of patient-controlled analgesia.

次要结局

  • Constipation(Up to 48hrs post-initiation of patient-controlled analgesia)
  • Nausea(Up to 48hrs post-initiation of patient-controlled analgesia)
  • Vomiting(Up to 48hrs post-initiation of patient-controlled analgesia)
  • Pruritus(Up to 48hrs post-initiation of patient-controlled analgesia)
  • Urinary Retention(Up to 48hrs post-initiation of patient-controlled analgesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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