DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Effects of Intravenous Lidocaine on Endometriosis Pain

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometriosis

Intervention: IV Lidocaine (Drug); IV diphenhydramine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Antje Barreveld, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Overall contact:
Antje M Barreveld, MD, Phone: 617-243-6298, Email: abarreveld@partners.org

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.

Clinical Details

Official title: Effects of Intravenous Lidocaine on Endometriosis Pain

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

Primary outcome: Numeric Pain Score

Secondary outcome:

Short Form McGill Pain Questionnaire 2

Brief Pain Inventory

Hospital Anxiety and Depression Scale

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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 (can be on hormonal therapy, excluding intrauterine

devices or 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

Locations and Contacts

Antje M Barreveld, MD, Phone: 617-243-6298, Email: abarreveld@partners.org

Brigham and Women's Hospital Pain Management Center, Boston, Massachusetts 02467, United States; Recruiting
Courtney Rust, Phone: 617-732-9810, Email: crust1@partners.org
Antje Barreveld, MD, Principal Investigator
Additional Information

Starting date: December 2010
Last updated: July 20, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017