The Efficacy of Intravenous Lidocaine Infusion in Chronic Unilateral Migraine Headache Clinical and Laboratory Assessment .Aprospective Randomized Double Blind Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Verbal analogue scale for pain
研究概览
简要总结
STUDY THE EFFICACY OF INTRAVENOUS LIDOCAINE INFUSION ON PATIENTS WITH CHRONICUNILATERAL MIGRAINE HEADACHE ..NO OF PATIENTS 80..WILLBE DIVIDED INTO 2 GROUPS..FIRST WILL RECEIVE MEDICAL TREATMENT PLUS LIDOCAINE INFUSION ONCE WEEKLY FOR 4 SUCCESIVE WEEKS ,OTHER WILL RECEIVE MEDICAL TREATMENT PLUS SALINE INFUSION SAME REGIMNE,FOLLOW UP USING MONTHLY MIGRAINE DAYS,VAS SCORE,MIDAS SCORE,QUALITY OF LIFE QUESTIONAIRE,PRE AND POST MEASUREMENT OF CALCITONIN GENE RELATED PEPTIDE
详细描述
Group A will receive medical treatment for migraine plus normal saline infusion,Group B will receive medical treatment plus lidocaine infusion at dose from 3 to 4 mg per kg,computer generated random number will be used to identify the selected blocks and give the sequence of patients allocation,guarantee equal random in each group a set of permuted blocks will be generated. Each block has 4 differently ordered treatment assignments.Block 1 (AABB),Block2(ABAB),Block3(BABA),Block 4(ABBA),Block5(BAAB),Block 6(BBAA).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (18-55) years for both genders.
- •Patients with chronic unilateral migraine headache for at least (3) month with VASscore more than (4).
- •Patient who failed to respond to conservative treatment as medical treatment algorithm including at least tow preventive trials.
- •Excusion criteria:
- •patient with disabling chronic disease or psychiatric illness
- •unstable cardiac arrhythmia
- •patient refusal red flags
排除标准
- 未提供
研究组 & 干预措施
infusion of saline
infusion saline for 4 successive weeks once weekly over 45 min
干预措施: Lidocaine IV (Drug)
lidocaine infusion
infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
Verbal analogue scale for pain
时间窗: 3 month
verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable
Monthly Migraine Days
时间窗: 3 Month
Number of Migraine Attacks Per Month More or less than (15) for chronicity
次要结局
- Migraine Specific Quality Of Life Questionaire(3 Month)
- Calcitonin Gene Related Peptide Biomarker.(3 Month)
- Migraine attack duration(3 Month)
- Migraine Disability Assessment Questionaire(3 Month)