Efficacy of GONB in Patients of Migraine

Phase 4

Completed

• Conditions: Chronic Migraine; Headache
• Interventions: Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine; Drug: Greater Occipital Nerve Block with 0.9% saline

• Registration Number: NCT05679765
• Lead Sponsor: Pain Medicine Department

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-26
• Status Verified: 2023-01
• Study First Posted: 2023-01-11
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group G	Greater Occipital Nerve Block with dexamethasone and lidocaine	Greater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache
Group G	Greater Occipital Nerve Block with 0.9% saline	Greater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache
Group S	Greater Occipital Nerve Block with 0.9% saline	Greater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo)
Group S	Greater Occipital Nerve Block with dexamethasone and lidocaine	Greater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo)

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy	12 weeks	Change in Pain score assessed on Numeric Rating Scale (NRS) which ranges from 0 to 10. 0 is no pain and 10 is maximum pain.

Secondary Outcome Measures

Name	Time	Method
Headache days	12 weeks	Number of headache days over the course of study period.

Trial Locations

Locations (1)

Pain Medicine Department; 🇵🇰 Lahore, Pakistan