Effects of Intravenous Lidocaine on Endometriosis Pain

NCT ID: NCT01968694

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV Lidocaine

IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes

Group Type: EXPERIMENTAL

IV Lidocaine

Intervention Type: DRUG

IV diphenhydramine

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes

Group Type: PLACEBO_COMPARATOR

IV diphenhydramine

Intervention Type: DRUG

Interventions

IV Lidocaine

Intervention Type: DRUG

IV diphenhydramine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Antje Barreveld, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antje Barreveld, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Newton-Wellesley Hospital

Locations

Brigham and Women's Hospital Pain Management Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P002903

Identifier Type: -

Identifier Source: org_study_id