A Phase 4 interventional study of Placebo and Bupivacaine in Migraine Disorders, sponsored by Mahidol University. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Mahidol University · Phase 4, Interventional, and Prevention
The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication.
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline
After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 108 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Had these type of headache in combination with migraine
Use Normal saline 3 ml as the injection agent
Drug: Placebo
Use 0.5% Bupivacaine 3ml as the injection agent
Drug: Bupivacaine
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL
change of Frequency headache day /month
by using headache diary
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
change of migraine attack day /month from headache diary
by using headache diary
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
change in severity of headache day per month (decrease of moderate-severe pain)
decrease of moderate-severe pain day per month compare to baseline by using headache diary
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Thai-Migraine Disability Assessment
Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability
Time frame: at Week 12,24 compare to baseline
Thai-Hospital Anxiety and Depression Scale
Thai-Hospital Anxiety and Depression Scale (Thai HADS) , divided into anxiety and depression part ,if either of the score in each depression or anxiety more than 11 mean abnormal
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Healthcare outcomes/quality of life
by EuroQoL- (EQ-5D) measured health-related quality of life with 5 dimension (mobility, health care, usual activity, Pain, Anxiety/depression and in each of them had 5 grading 1-5 by 1 means no problem and 5 means extreme problem) after having score in each dimension, calculated utility score would be done
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Patient's reported outcome measurement (PGI-C)
Patient's reported outcome measurement (PGI-C), score grading 1-7 by 1 very much worse to very much improved , 7 means very much worse
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Plan to share: Undecided — will be consider again after data collection
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Mahidol University