A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache
Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache. 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.
Drug: lidocaine plus bupivicaine
Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population|
- To compare the efficacy of greater occipital nerve (GON) block with lidocaine 2% and bupivicaine 0.5% (treatment A), versus lidocaine 2% and bupivicaine 0.5% plus triamcinolone (kenalog) 40mg (treatment B), in treatment of daily or near daily headache.
- Efficacy will be assessed as decrease in headache pain, as measured on an 11-point verbal scale (0=no pain, 10=excruciating pain). Efficacy will be compared between treatment groups and to historical baseline within each group.
- To assess the tolerability of the two treatment protocols (treatment A versus treatment B)
- To evaluate the effect of treatment on neck pain in the two groups compared to historical baseline, and between the two treatment groups.
- 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.
- To evaluate effect of treatment on acute-medication use, compared to historical baseline, and between the two treatment groups.
|Study Start Date:||June 2005|
|United States, Pennsylvania|
|Jefferson Headache Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Stephen D Silberstein, MD||Thomas Jefferson University, Jefferson Headache Center|