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临床试验/NCT06725485
NCT06725485已完成4 期

Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study

The Methodist Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年7月2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
入组人数
18
试验地点
1
主要终点
Opioid consumption on post-operative day 3

研究概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.

详细描述

The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Males or females age > 18 years admitted to surgical ICU.
  • Severe acute pain with pain scale > 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries.
  • Women of childbearing age must have a negative urine/serum pregnancy test.

排除标准

  • Regional anesthesia during surgery
  • Heart failure with ejection fraction < 20%.
  • Allergy to amide local anesthetics
  • Neuraxial anesthesia during surgery
  • Post-liver transplant patients
  • Hemodynamically unstable patients on two or more vasopressors
  • Child-Pugh Class C or MELD >20
  • Any investigational drug use within 30 days before enrollment
  • Pregnant or lactating females
  • Patients with chronic opioid-dependence
  • Intubated and mechanically ventilated patients on intensive care unit analgo-sedation
  • Subjects who do not agree to participate or may be non-compliant with study schedules or procedures.

研究组 & 干预措施

Low-Dose Lidocaine Infusion

Experimental

Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.

干预措施: Low-Dose Lidocaine (Drug)

结局指标

主要结局

Opioid consumption on post-operative day 3

时间窗: Post-operative day 3

Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents

次要结局

  • Pain Scale at 72 Hours Post-Surgery(Post-operative day 3)
  • Opioid-Free Days(Time of surgery through the end of post-operative day 3)
  • Time Until Return in bowel function(Time of surgery through discharge, up to 30 days)
  • Return to Oral Feeding(Time of surgery through discharge, up to 30 days)
  • Post-operative intensive care unit length of stay(Time of surgery through intensive care unit discharge, up to 1 year)
  • Post-operative hospital length of stay(Time of surgery through hospital discharge, up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hina Faisal

Assistant Professor of Clinical Surgery

The Methodist Hospital Research Institute

研究点 (1)

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