NCT05679765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 7, 2022

Last Update Submit

January 11, 2023

Conditions

Chronic MigraineHeadache

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Headache days

    12 weeks

Study Arms (2)

Group G

EXPERIMENTAL

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 lidocaineDrug: Greater Occipital Nerve Block with 0.9% saline

Group S

ACTIVE COMPARATOR

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 lidocaineDrug: Greater Occipital Nerve Block with 0.9% saline

Interventions

Greater Occipital Nerve Block with dexamethasone and lidocaineDRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Also known as: GONB with dexamethasone and lidocaine
Group GGroup S
Greater Occipital Nerve Block with 0.9% salineDRUG

Ultrasound guided Greater occipital nerve block on the side of headache

Also known as: GONB with 0.9% saline
Group GGroup S

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Medicine Department

Lahore, Pakistan

Location

MeSH Terms

Conditions

Headache

Interventions

DexamethasoneLidocaineSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Moazzam Ali

    Pain Medicine Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Head Of Department

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 11, 2023

Study Start

April 1, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

PA(1)