跳至主要内容
临床试验/NCT07475520
NCT07475520已完成不适用

Comparative Study of Lidocaine IV Injection With Two Different Doses for Patients With Neuropathic Pain Who Undergoing Mastectomy for Cancer Breast

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
To assess neuropathic pain scale

研究概览

简要总结

cancer has become the most common malignancy affecting women worldwide, and its incidence is increasing annually. According to the Global Cancer Observatory (GLOBOCAN) 2020 published by the International Agency for Research on Cancer of the World Health Organization, female breast cancer is the cancer with the highest number of new cases worldwide significant number of patients experiencing moderate to severe acute pain (30-50%) and developing chronic post-surgical pain (CPSP) (25-68%)

详细描述

Various drugs have been used for neuropathic pain management Opioid agonists, but endocrine and immunologic alterations were reported. Concerns about an increase in opioid prescription that is associated with overdose mortality, misuse and other opioid related morbidity resulted in tracking daily doses and monitoring patients, who require higher daily doses, more closely, Tramadol has been found moderately effective in peripheral neuropathic pain, yet it should be used with caution in elderly patients for risk of confusion. Other medications developed for other indications like anti-depressants and anti-convulsants. Tricyclic antidepressants (TCA's), selective serotonin nor epinephrine reuptake inhibitors (SNRI's), monoamine oxidase inhibitors (MAO inhibitors) are antidepressant agents that reduce chronic neuropathic pain in addition to their role in treatment of depression and pain related sleep interference, However, their induced sedation and dizziness interfered with patients' quality of life and their doses as well should be monitored for patients with renal insufficiency However, TCA's may cause cardiac conduction block, orthostatic hypotension, sedation, and confusion. SNRI's and MAO inhibitors cause nausea, loss of appetite, constipation, sedation, and anxiety Lidocaine is an amide local anesthetic with a wide range of mechanisms of action. Lidocaine found to successfully provide pain relief in several chronic neuropathic conditions that have failed other treatment modalities when given in low dose intravenous infusion. Lidocaine infusion is inexpensive, relatively easily administrated and has been safely used with few side effects. It also has opioid sparing effect.

It has been reported that even single infusion may lead to prolonged analgesia that could allow the reduction of use of co-analgesics and related toxicities, Hence, in the current study, the investigators aim to compare of lidocaine iv injection with two different doses for patients with neuropathic pain developed after mastectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patients ≥ 18years.
  • Females with neuropathic pain following mastectomy for cancer breast.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients on other drugs with intolerable side effects.
  • Patients undergoing breast surgery

排除标准

  • Patients with known hypersensitivity to lidocaine.
  • Patients with history of uncontrolled seizures.
  • Patients with second- or third-degree heart block.
  • Patients with altered cognitive dysfunction.

研究组 & 干预措施

Lidocaine 2 mg/kg

Active Comparator

Patients receive 2 mg/kg lidocaine IV injection over 30 minutes.

干预措施: Lidocaine 2% (Drug)

Lidocaine 6 mg/kg

Active Comparator

Patients receive 6 mg/kg lidocaine IV injection over 30 minutes

干预措施: Lidocaine (Drug)

结局指标

主要结局

To assess neuropathic pain scale

时间窗: assessed at 0, 15, 30, 1 hour. 2 hours and 24 hours and 1 week after injection

a 10-item tool designed to assess the distinct qualities (e.g., burning, freezing, stinging) and intensity of nerve-related pain, using 0-10 numerical ratings for each.This scale measures 10 specific qualities associated with neuropathic pain; 7 of the 10 pain qualities contain the words: intense, sharp, hot, dull, cold, and itchy to characterize the patient's pain, and the word "sensitive" describes the patient's pain reaction to light touch or clothing. One item describes the pain in regard to time (all the time or some of the time). The ninth item describes the overall unpleasantness of the pain, and the last item indicates the intensity of the deep and surface pain. It helps distinguish neuropathic from other pain types.

次要结局

未报告次要终点

研究者

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

Ahmed Shaaban Glall Ismail

Investigator

Cairo University

研究点 (1)

Loading locations...

相似试验