Effects of Intravenous Lidocaine on Endometriosis Pain

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Pfizer
• Treatments: Diphenhydramine; Lidocaine; Promethazine

Criteria

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 mexiletene

• Having or showing signs and symptoms of liver disease