NCT06432127

Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis

Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication : A Randomized Controlled Study in Thailand

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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 * Normal saline * 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS)

Detailed description

* Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria * Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent * After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine * Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0) * At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure * According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group * First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0) * Telemedicine Follow up at week 2 * Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4) * Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection * Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	Placebo	Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
DRUG	Bupivacaine	Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-05-29
• Last updated: 2024-05-29

Locations

1 site across 1 country: Thailand