The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Alexandria University

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Migraine, Headache

Treatments: Drug: Lidocaine IV

Study type: Interventional

Funder types: Other

Identifiers

NCT06109389

E/C.S/N.T71/2023

Details and patient eligibility

About

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

Full description

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

infusion of saline

Experimental group

Description:

infusion saline for 4 successive weeks once weekly over 45 min

Treatment:

Drug: Lidocaine IV

lidocaine infusion

Active Comparator group

Description:

infusion of lidocaine 3 mg per kg for 2 successive weeks then 4 mg per kg for 2 successive weeks

Treatment:

Drug: Lidocaine IV