Efficacy of GONB in Patients of Migraine

NCT ID: NCT05679765

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-31

Brief Summary

The study was carried to determine the analgesic efficacy of greater occipital nerve block in patients of migraine. It was a randomised controlled which took place from april 2022 - october 2022. Fifty patients suffering from migraine were included in the study. Patients in Group G were given greater occipital nerve block (GONB) with lignocaine and dexamethasone under ultrasound guidance while those in Group S were given saline 0.9% as placebo. Pain score using Numeric Rating Scale and number of headache days was assessed at four,eight and twelve weeks after the procedure as a primary outcome. Total headache days were recorded as a secondary outcome.

Conditions

Chronic Migraine; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group G

Greater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache

Group Type: EXPERIMENTAL

Greater Occipital Nerve Block with dexamethasone and lidocaine

Intervention Type: DRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Greater Occipital Nerve Block with 0.9% saline

Intervention Type: DRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Group S

Greater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo)

Group Type: ACTIVE_COMPARATOR

Greater Occipital Nerve Block with dexamethasone and lidocaine

Intervention Type: DRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Greater Occipital Nerve Block with 0.9% saline

Intervention Type: DRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Interventions

Greater Occipital Nerve Block with dexamethasone and lidocaine

Ultrasound guided Greater occipital nerve block on the side of headache

Intervention Type: DRUG

Greater Occipital Nerve Block with 0.9% saline

Ultrasound guided Greater occipital nerve block on the side of headache

Intervention Type: DRUG

Other Intervention Names

GONB with dexamethasone and lidocaine; GONB with 0.9% saline

Eligibility Criteria

Inclusion Criteria

• Patients between 18 to 60 years
• diagnosed case of migraine

Exclusion Criteria

• Patients with known allergies to local anaesthetics
• pregnancy
• history of cranial or cervical surgery
• head injury
• headaches secondary to medication overuse
• patients with uncontrolled systemic disease like blood pressure, diabetes mellitus
• hypo or hyperthyroidism
• patient who had already received GONB or botulinum toxin type A therapy within last 6 months
• major psychiatric disorder
• history of chronic pain syndromes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pain Medicine Department

OTHER

Sponsor Role: lead

Responsible Party

Moazzam Ali

Doctor, Head Of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moazzam Ali

Role: PRINCIPAL_INVESTIGATOR

Pain Medicine Department

Locations

Pain Medicine Department

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

GONB for migraine

Identifier Type: -

Identifier Source: org_study_id