Effects of Intravenous Lidocaine on Endometriosis Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Endometriosis |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | December 2010 |
| End Date: | December 2016 |
| Contact: | Antje M Barreveld, MD |
| Email: | abarreveld@partners.org |
| Phone: | 617-243-6298 |
We are doing this research study to find out if intravenous (in your vein, "IV") lidocaine
can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved
intravenous lidocaine to treat irregular heart beats, but the FDA has not approved
intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used
for more than 25 years to treat different acute and chronic pain conditions but has not yet
been studied for endometriosis pain.
This is a cross-over trial over two months where one month you will receive the active
medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,
commonly known as benadryl). We will compare the effect on pain from endometriosis of
lidocaine to active placebo.
can lessen pain from endometriosis. The U.S. Food and Drug Administration (FDA) has approved
intravenous lidocaine to treat irregular heart beats, but the FDA has not approved
intravenous lidocaine to treat pain from endometriosis. Intravenous lidocaine has been used
for more than 25 years to treat different acute and chronic pain conditions but has not yet
been studied for endometriosis pain.
This is a cross-over trial over two months where one month you will receive the active
medication (lidocaine) and one month you will receive the active placebo (diphenhydramine,
commonly known as benadryl). We will compare the effect on pain from endometriosis of
lidocaine to active placebo.
Inclusion criteria:
- Reproductive age women ages 18 - 50
- Endometriosis diagnosed laparoscopically or by primary care physician or gynecologist
using clinical criteria
- Pain for > 6 months
- Pain most intense around time of menstrual cycle. Pain at least 5 on a 0-10 scale.
- Receiving regular monthly menses (cannot be receiving Depo-provera injections)
Exclusion criteria:
- Pregnant or breastfeeding
- On lupron therapy
- History of myocardial infarction or cardiac arrhythmias including
Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart
block in the absence of a pacemaker
- History of seizure disorder
- Significant anxiety, psychosis or other cognitive disorder limiting completion of
study procedures
- History of alcohol or substance abuse
- Chronic pain symptoms other than chronic pelvic pain (excluding migraine pain)
- Known hypersensitivity to amide type anesthetics
- Known hypersensitivity to diphenhydramine (benadryl)
- History of treatment with lidocaine or mexilitene
- Having or showing signs and symptoms of liver disease
We found this trial at
1
site
Boston, Massachusetts 02467
Principal Investigator: Antje Barreveld, MD
Phone: 617-243-6298
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