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

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203294
First received: September 13, 2005
Last updated: January 22, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Migraine
 Drug: lidocaine plus bupivicaine
Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203294

Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Stephen D Silberstein, MD Thomas Jefferson University, Jefferson Headache Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203294     History of Changes
Other Study ID Numbers: GONB/ STE/ 01
Study First Received: September 13, 2005
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Anesthetics, Local
Bupivacaine
Lidocaine
Anesthetics
Triamcinolone hexacetonide
 Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on June 18, 2013