Effects of Intravenous Lidocaine on Endometriosis Pain

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: IV Lidocaine; Drug: IV diphenhydramine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02467
      • Brigham and Women's Hospital Pain Management Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Lidocaine; IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes	Drug: IV Lidocaine
Placebo Comparator: IV diphenhydramine; IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes	Drug: IV diphenhydramine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Form McGill Pain Questionnaire 2	Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220. Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment: (30 minutes post-treatment value - BL pre-infusion value) (1 week post-treatment value - BL pre-infusion value) (1 month post-treatment value - BL pre-infusion value)	30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Brief Pain Inventory (BPI): Pain on Average	The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine. Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment: (1 day post-treatment value - BL pre-infusion value) (1 week post-treatment value - BL pre-infusion value) (1 month post-treatment value - BL pre-infusion value)	1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Change in Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale. A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case). Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment: (1 day post-treatment value - BL pre-infusion value) (1 week post-treatment value - BL pre-infusion value) (1 month post-treatment value - BL pre-infusion value)	1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Pfizer
• Investigators: Principal Investigator: Antje Barreveld, MD, Brigham and Women's Hospital, Newton-Wellesley Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; endometriosis; intravenous lidocaine
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Lidocaine; Diphenhydramine; Promethazine
• Other Study ID Numbers: 2010P002903