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

Thomas Jefferson University

Status: Completed

Conditions: Migraine

Treatments: Drug: lidocaine, bupivicaine and saline; Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)

Study type: Interventional

Funder types: Other

Identifiers

NCT00203294

GONB/ STE/ 01

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Lidocaine 2%, Bupivicaine 0.5% and saline

Active Comparator group

Description:

Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.

Treatment:

Drug: lidocaine, bupivicaine and saline

Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg

Active Comparator group

Description:

Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.

Treatment:

Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)