Effects of Intravenous Lidocaine on Endometriosis Pain

Completed · Not applicable

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT01968694

Run by

Brigham and Women's Hospital

People needed

20

Starts

2010-12-01

Expected to finish

2016-06-01

Last updated by the study team

2017-06-07

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 mexiletene
• Having or showing signs and symptoms of liver disease

Where it is running

• Brigham and Women's Hospital Pain Management Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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