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Efficacy of GONB in Patients of Migraine

Sponsor
Pain Medicine Department (Other)
Overall Status
Completed
CT.gov ID
NCT05679765
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine
  • Drug: Greater Occipital Nerve Block with 0.9% saline
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Aug 31, 2022
Actual Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group G

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

Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine
Ultrasound guided Greater occipital nerve block on the side of headache
Other Names:
  • GONB with dexamethasone and lidocaine

    • Drug: Greater Occipital Nerve Block with 0.9% saline
    Ultrasound guided Greater occipital nerve block on the side of headache
    Other Names:
  • GONB with 0.9% saline

    		•
    Active Comparator: Group S

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

    Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine
    Ultrasound guided Greater occipital nerve block on the side of headache
    Other Names:
  • GONB with dexamethasone and lidocaine

    • Drug: Greater Occipital Nerve Block with 0.9% saline
    Ultrasound guided Greater occipital nerve block on the side of headache
    Other Names:
  • GONB with 0.9% saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Headache days [12 weeks]

      Number of headache days over the course of study period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pain Medicine Department Lahore Pakistan

    Sponsors and Collaborators

    • Pain Medicine Department

    Investigators

    • Principal Investigator: Moazzam Ali, Pain Medicine Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moazzam Ali, Doctor, Head Of Department, Pain Medicine Department
    ClinicalTrials.gov Identifier:
    NCT05679765
    Other Study ID Numbers:
    • GONB for migraine
    First Posted:
    Jan 11, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders
    Headache
    Dexamethasone
    Dexamethasone acetate
    Lidocaine
    BB 1101

    Study Results

    No Results Posted as of Jan 12, 2023