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Clinical trial

Chronic Migraine Prophylaxis: Comparative Study Between Ultrasound-Guided Greater Occipital Nerve Block and Medical Treatment

ID
Name
35459/4/22
Description
The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.
Trial arms
Trial start
2022-05-01
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Recruiting
Treatment
Greater Occipital Nerve Block
Patients will receive Greater Occipital Nerve Block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. Ultrasound-guided GONB will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery
Arms:
Greater Occipital Nerve Block
Medical Treatment
Patients who will receive medical treatment
Arms:
Medical Treatment
bupivacaine or onabotulinum toxin A injection.
bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.
Arms:
Greater Occipital Nerve Block
Size
80
Primary endpoint
severity of headache
Follow up after 3 months
Eligibility criteria
Inclusion Criteria: 1. Age \> 18 years old. 2. Both sexes. 3. Patients with chronic migraine. Exclusion Criteria: 1. Age less than 18 years. 2. Patients with medication overuse headache. 3. Patients who had used acute pain medications within 24 hours prior to the study visit. 4. History of injury to the area of the GON. 5. Any prior adverse reactions to local anesthetics. 6. Patients with impaired sensation in the occipital area. 7. Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-11-08

1 organization

1 product

3 indications

Organization
Tanta University
Product
Bupivacaine or Onabotulinum Toxin A Injection
Indication
Occipital Neuralgia
Indication
Medical Treatment
Indication
Migraine