Effects of Intravenous Lidocaine on Endometriosis Pain

Endometriosis Clinical Trial

Official title:

Effects of Intravenous Lidocaine on Endometriosis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968694
• Other study ID #: 2010P002903
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: October 5, 2016
• Start date: December 2010
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• IV Lidocaine

• IV diphenhydramine

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital Pain Management Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Score		Two Months	No
Secondary	Short Form McGill Pain Questionnaire 2		Two Months	No
Secondary	Brief Pain Inventory		Two Months	No
Secondary	Hospital Anxiety and Depression Scale		Two Months	No