Effects of Intravenous Lidocaine on Endometriosis Pain

NCT01968694 | Completed Results

• 1 other identifier: 2010P002903
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

endometriosis; chronic pain; intravenous lidocaine

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale (VAS)

  Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain). Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete: (15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)

  15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)

Secondary Outcomes (3)

• Change in Short Form McGill Pain Questionnaire 2

  30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)

• Change in Brief Pain Inventory (BPI): Pain on Average

  1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)

• Change in Hospital Anxiety and Depression Scale (HADS)

  1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)

Study Arms (2)

IV Lidocaine

EXPERIMENTAL

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

Drug: IV Lidocaine

IV diphenhydramine

PLACEBO COMPARATOR

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

Drug: IV diphenhydramine

Interventions

IV Lidocaine DRUG

IV Lidocaine

IV diphenhydramine DRUG

IV diphenhydramine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Brigham and Women's Hospital Pain Management Center

Boston, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Endometriosis; Chronic Pain

Interventions

Lidocaine; Diphenhydramine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Antje M Barreveld
• Organization: Brigham & Women's Hospital

abarreveld@partners.org

617-243-6298

Study Officials

• Antje Barreveld, MD

  Brigham and Women's Hospital, Newton-Wellesley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: December 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-05

Locations

US (1)