A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache

Migraine Clinical Trial

Official title:

Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203294
• Other study ID #: GONB/ STE/ 01
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 7, 2014
• Start date: June 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, age 18-65 inclusive

• Patients who have chronic daily headache (15 or more headache days per month) for at least 3 months prior to enrollment in the study.

• Headache level should be 5/10 or more at time of GON block.

• Patients should have posterior cervical muscle tenderness at time of nerve block.

Exclusion Criteria:

• Patients who had surgery or any other invasive procedure in the occipital area.

• Patients with abnormal sensory findings on examination or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).

• Patients diagnosed with cluster headache

• Patients with skin diseases that may affect skin sensation.

• Patients who are cognitively impaired.

• Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.

• Patients who are pregnant or breast-feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• lidocaine, bupivicaine and saline
lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
• lidocaine plus bupivicaine plus triamcinolone (steroid)
lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.

Locations

Country	Name	City	State
United States	Jefferson Headache Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain	Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment	20 minutes	No
Primary	Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.		20 minutes	No
Secondary	To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.		20 minutes	No
Secondary	To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.		20 minutes	No