Efficacy of GONB in Patients of Migraine

January 11, 2023 updated by: Moazzam Ali, Pain Medicine Department

Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Pain Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic efficacy
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache days
Time Frame: 12 weeks
Number of headache days over the course of study period.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain Medicine Department

Investigators

  • Principal Investigator: Moazzam Ali, Pain Medicine Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 26, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GONB for migraine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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