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

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

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Lidocaine 1% Injectable Solution

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cem Bölük, M.D.; Phone Number: +902124143000; Email: cem_boluk@hotmail.com
• Study Contact Backup: Name: Cem Bölük; Phone Number: +902124143000; Email: cem_boluk@hotmail.com

Study Locations

• Turkey
  • Kartal/Soğanlık
    • Afyonkarahisar, Kartal/Soğanlık, Turkey, 03217
      • Afyonkarahisar University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Classical Trigeminal Neuralgia

Exclusion Criteria:

• Secondary Trigeminal Neuralgia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; %1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks	Drug: Lidocaine 1% Injectable Solution; Greater occipital nerve and cervical region injections once a week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lidocaine; Trigeminal Neuralgia; Greater Occipital Nerve Block
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2011-KAEK-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No