NCT04505280

Brief Summary

The aim of this study is to investigate the efficacy of greater occipital nerve block and cervical injections with lidocaine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

July 31, 2020

Last Update Submit

February 18, 2023

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal NeuralgiaGreater Occipital Nerve BlockLidocaine

Outcome Measures

Primary Outcomes (2)

  • Efficacy on pain severity

    Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain

    3 months

  • Efficacy on pain frequency

    Pain frequency per day

    3 months

Study Arms (1)

Active

EXPERIMENTAL

%1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks

Drug: Lidocaine 1% Injectable Solution

Interventions

Lidocaine 1% Injectable SolutionDRUG

Greater occipital nerve and cervical region injections once a week for 4 weeks

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Classical Trigeminal Neuralgia

You may not qualify if:

  • Secondary Trigeminal Neuralgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar University of Health Sciences

Afyonkarahisar, Kartal/Soğanlık, 03217, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 10, 2020

Study Start

July 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 30, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)