Potential Role of Intravenous Lidocaine Versus Intravenous Ketamine for Pain Management in Fibromyalgia Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- : Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS).
研究概览
简要总结
The aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous ketamine in treatment of fibromyalgia patients.
详细描述
Adult fibromyalgia patients (25 to 50 years old) suffering from with uncontrolled pain perception will be enrolled although maximum medical treatment is prescribed.
Pre-procedure study tools:
- patients are on regular medical treatment in the form of Cymbalta 60 mg/day, Triptyzol 25 mg/day, and Gabapantin 100 mg/day.
- The following will be done for all the patients:
- Full medical history.
- Thorough clinical examination.
- Visual analogue scale for pain assessment pre and post administration of the study medications.
- FM impact Questionnaire (FIQR) for assessment quality of life pre and post administration of the study medications.
- ECG.
- Laboratory Investigations will include:
Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) with Westergren blot method in (mm) after 1st hour (mm/1st hour).
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
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FM, diagnosed according to the American College of Rheumatology (ACR) 2016 diagnostic criteria for FM. (Wolfe, F., Clauw, D. J., Fitzcharles, M. A., et al., 2016)
排除标准
- •- Known hypersensitivity to any of the given drugs or one of their derivatives (lidocaine or ketamine).
- •Known Arrhythmia (Supraventricular or ventricular).
- •Pregnant females.
研究组 & 干预措施
Group A:Lidocaine group
5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks
干预措施: Lidocaine group (Drug)
Group B:Ketamine group
0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
干预措施: Ketamine group (Drug)
Group C:Placebo group
Placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
干预措施: Placebo group (Drug)
结局指标
主要结局
: Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS).
时间窗: Assessment will be done weekly for 3 weeks. First assessment will be 1week after first procedure ,on the same day of 2nd injection. 2nd assessment will be on the same day of the 3rd injection . 3rd assessment will be done 1 week after third injection
Questionnaire to assess degree of pain relieve and improvement of physical activity, a scale from 0-10 where 0 is no pain or limitation and 10 is the worst unbearable pain perception. Asucess is achieved when decline in the scale takes place 3 points out of 10 , where at least reach 5
次要结局
- : Quality of life questionnaire that measures the patients' physical and psychological well-being.(Pre-procedure measurement and another measurement will be assessed one month after first procedure)
研究者
maha sadek El Derh
Assistant professor of Anesthesia
Ain Shams University