Greater Occipital Nerve and Cervical Region Injection in... | NCT04505280

Studies
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia

NCT04505280

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Status

Completed

Last Update Posted

Feb 21, 2023Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Trigeminal Neuralgia

Interventions

Lidocaine 1% Injectable Solution

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Jul 31, 2020

First Submission Date that Met QC Criteria

Aug 5, 2020

First Posted Date

Aug 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2023

Last Update Posted Date

Feb 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cem Bölük, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Dr. Lutfi Kirdar Kartal Training and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

After being informed about the study and potantiel risks, all patients giving informed consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	%1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks	Drug: Lidocaine 1% Injectable Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine 1% Injectable Solution	Drug	Greater occipital nerve and cervical region injections once a week for 4 weeks	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Classical Trigeminal Neuralgia

Exclusion Criteria:

Secondary Trigeminal Neuralgia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Afyonkarahisar University of Health Sciences		Afyonkarahisar	Kartal/Soğanlık	03217	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014277	Trigeminal Neuralgia

Ancestor Terms

ID	Term
D020433	Trigeminal Nerve Diseases
D005156	Facial Neuralgia
D005155	Facial Nerve Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided