Clinical trial NCT01968694: Effects of Intravenous Lidocaine on Endometriosis Pain
Official title: Effects of Intravenous Lidocaine on Endometriosis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
chronic pain
intravenous lidocaine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-10-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS)
timeFrame: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
Secondary outcomes:
measure: Change in Short Form McGill Pain Questionnaire 2
timeFrame: 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
measure: Change in Brief Pain Inventory (BPI): Pain on Average
timeFrame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital Pain Management Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Newton-Wellesley Hospital
name: Antje Barreveld, MD
role: PRINCIPAL_INVESTIGATOR
References: