CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 enrolled
Drug / intervention
Lidocaine Hydrochloride +1 moredrug
Likely dose
Lidocaine Hydrochloride 1 mlfrom record
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Search/NCT04491474
NCT04491474Phase 4Completed

Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Treatment Methods Individually and in Combination With Placebo in an Acute Migraine Attack in the Emergency Department, a Prospective, Double Blind, Randomized Controlled Study

Dr. Lutfi Kirdar Kartal Training and Research Hospital·interventional·Posted Jul 29, 2020·Updated Mar 16, 2021

In Brief

A Phase 4 clinical trial evaluating Lidocaine Hydrochloride and Placebo for Migraine Disorders. Completed, enrolled 128 participants across 1 site.

Detailed Summary

Aim Acute migraine attack is a clinical condition that is frequently encountered in emergency departments and varies from patient to patient in terms of treatment modalities. There are many different treatments whose effectiveness has been proven by concrete evidence(1). Drug treatments applied to patients are generally given intravenously or intramuscularly. Non-steroidal anti-inflammatory drugs, metoclopramide and intravenous magnesium therapy is generally used for treatment in emergency departments (1). The effectiveness of supraorbital nerve blockade and great occipital nerve blockade in migraine treatment and prophylaxis has been proven in many studies(2-6). The aim of this study is to discuss the effectiveness of supraorbital and great occipital nerve blockade treatments in acute migraine attack, when combined or used individually.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 29, 2020
Enrollment StartAug 15, 2020
Primary CompletionMar 14, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.9 years ago

Interventions

Lidocaine Hydrochloridedrug

While performing these procedures, 1 ml of 2% lidocaine hydrochloride and 1 ml of %0.9 saline will be used for creating a solution of 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch

Placebodrug

There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.