The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache

Chronic Migraine, Headache Clinical Trial

Official title:

The Efficacy of Intravenous Lidocaine Infusion in Chronic Unilateral Migraine Headache Clinical and Laboratory Assessment .Aprospective Randomized Double Blind Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06109389
• Other study ID #: E/C.S/N.T71/2023
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Drug:
• Lidocaine IV
LIDOCAINE INFUSION STARTED 3 MG PER KG FOR 2 SUCCESSIVE WEEKS ,THEN 4 MG PER KG FOR ANOTHER 2 WEEKS .ONCE WEEKLY,other group saline infusion once weekly for 4 successive weeks

Locations

Country	Name	City	State
Egypt	Alexandria University,Medical Research Institute	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Aggarwal M, Puri V, Puri S. Serotonin and CGRP in migraine. Ann Neurosci. 2012 Apr;19(2):88-94. doi: 10.5214/ans.0972.7531.12190210. — View Citation

Al Ghadeer HA, AlSalman SA, Albaqshi FM, Alsuliman SR, Alsowailem FA, Albusror HA, AlAbdi ZI, Alwabari EM, Alturaifi ZA, AlHajji AM. Quality of Life and Disability Among Migraine Patients: A Single-Center Study in AlAhsa, Saudi Arabia. Cureus. 2021 Nov 2; — View Citation

Andreou AP, Edvinsson L. Mechanisms of migraine as a chronic evolutive condition. J Headache Pain. 2019 Dec 23;20(1):117. doi: 10.1186/s10194-019-1066-0. — View Citation

Di Tanna GL, Porter JK, Lipton RB, Brennan A, Palmer S, Hatswell AJ, Sapra S, Villa G. Migraine day frequency in migraine prevention: longitudinal modelling approaches. BMC Med Res Methodol. 2019 Jan 23;19(1):20. doi: 10.1186/s12874-019-0664-5. — View Citation

Eigenbrodt AK, Ashina H, Khan S, Diener HC, Mitsikostas DD, Sinclair AJ, Pozo-Rosich P, Martelletti P, Ducros A, Lanteri-Minet M, Braschinsky M, Del Rio MS, Daniel O, Ozge A, Mammadbayli A, Arons M, Skorobogatykh K, Romanenko V, Terwindt GM, Paemeleire K, — View Citation

Fink R. Pain assessment: the cornerstone to optimal pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):236-9. doi: 10.1080/08998280.2000.11927681. — View Citation

Hand PJ, Stark RJ. Intravenous lignocaine infusions for severe chronic daily headache. Med J Aust. 2000 Feb 21;172(4):157-9. doi: 10.5694/j.1326-5377.2000.tb125538.x. — View Citation

Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012 Feb;16(1):86-92. doi: 10.1007/s11916-011-0233-z. — View Citation

Lipton RB, Diamond S, Reed M, Diamond ML, Stewart WF. Migraine diagnosis and treatment: results from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):638-45. doi: 10.1046/j.1526-4610.2001.041007638.x. — View Citation

Mungoven TJ, Henderson LA, Meylakh N. Chronic Migraine Pathophysiology and Treatment: A Review of Current Perspectives. Front Pain Res (Lausanne). 2021 Aug 25;2:705276. doi: 10.3389/fpain.2021.705276. eCollection 2021. — View Citation

Myles PS, Urquhart N. The linearity of the visual analogue scale in patients with severe acute pain. Anaesth Intensive Care. 2005 Feb;33(1):54-8. doi: 10.1177/0310057X0503300108. — View Citation

Schoenen J, Timmermans G, Nonis R, Manise M, Fumal A, Gerard P. Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes. Front Neurol. 2021 Dec 10;12:805334. doi: 10.3389/ — View Citation

Schwenk ES, Walter A, Torjman MC, Mukhtar S, Patel HT, Nardone B, Sun G, Thota B, Lauritsen CG, Silberstein SD. Lidocaine infusions for refractory chronic migraine: a retrospective analysis. Reg Anesth Pain Med. 2022 Jul;47(7):408-413. doi: 10.1136/rapm-2 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monthly Migraine Days	Number of Migraine Attacks Per Month More or less than (15) for chronicity	3 Month
Primary	Verbal analogue scale for pain	verbal analogue scale for pain from( 0) to( 10) as( 0) no pain( 10) severe pain untolerable	3 month
Secondary	Migraine attack duration	Duration of each attack from (4) hours to (72) hours	3 Month
Secondary	Calcitonin Gene Related Peptide Biomarker.	Measurement of CGRP before and after( 1) month from first infusion treatment	3 Month
Secondary	Migraine Specific Quality Of Life Questionaire	14 questions ,each one measured from ( 1) never affect to(6) always affect ,answers summed for all questions value is obtained	3 Month
Secondary	Migraine Disability Assessment Questionaire	(0) Absent of disability,(270) Extremely severe disability,more than (21) severe disability	3 Month