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Efficacy of GONB in Patients of Migraine

Primary Purpose

Chronic Migraine, Headache

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Greater Occipital Nerve Block with dexamethasone and lidocaine
Greater Occipital Nerve Block with 0.9% saline
Sponsored by
Pain Medicine Department
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Migraine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Medicine Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group G

Group S

Arm Description

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

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

Outcomes

Primary Outcome Measures

Analgesic efficacy
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

Headache days
Number of headache days over the course of study period.

Full Information

First Posted
December 7, 2022
Last Updated
January 11, 2023
Sponsor
Pain Medicine Department
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1. Study Identification

Unique Protocol Identification Number
NCT05679765
Brief Title
Efficacy of GONB in Patients of Migraine
Official Title
Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Medicine Department

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group G
Arm Type
Experimental
Arm Description
Greater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache
Arm Title
Group S
Arm Type
Active Comparator
Arm Description
Greater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo)
Intervention Type
Drug
Intervention Name(s)
Greater Occipital Nerve Block with dexamethasone and lidocaine
Other Intervention Name(s)
GONB with dexamethasone and lidocaine
Intervention Description
Ultrasound guided Greater occipital nerve block on the side of headache
Intervention Type
Drug
Intervention Name(s)
Greater Occipital Nerve Block with 0.9% saline
Other Intervention Name(s)
GONB with 0.9% saline
Intervention Description
Ultrasound guided Greater occipital nerve block on the side of headache
Primary Outcome Measure Information:
Title
Analgesic efficacy
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Headache days
Description
Number of headache days over the course of study period.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moazzam Ali
Organizational Affiliation
Pain Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Medicine Department
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Efficacy of GONB in Patients of Migraine

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