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Effects of Intravenous Lidocaine on Endometriosis Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Antje Barreveld, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01968694
First received: October 21, 2013
Last updated: October 15, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention
Endometriosis
Drug: IV Lidocaine
Drug: IV diphenhydramine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intravenous Lidocaine on Endometriosis Pain

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Numeric Pain Score [ Time Frame: Two Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short Form McGill Pain Questionnaire 2 [ Time Frame: Two Months ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: Two Months ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Two Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Lidocaine
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes or normal saline 0.9% same volume given and infused over 30 minutes.
Drug: IV Lidocaine Drug: IV diphenhydramine
Placebo Comparator: IV diphenhydramine
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes or normal saline 0.9% equal volume dosed as above.
Drug: IV Lidocaine Drug: IV diphenhydramine

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 mexilitene
  • Having or showing signs and symptoms of liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968694

Contacts
Contact: Antje M Barreveld, MD 617-243-6298 abarreveld@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Pain Management Center Recruiting
Boston, Massachusetts, United States, 02467
Contact: Antje Barreveld, MD    617-243-6298    bwhlidocainestudy@gmail.com   
Principal Investigator: Antje Barreveld, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Pfizer
Investigators
Principal Investigator: Antje Barreveld, MD Brigham and Women's Hospital, Newton-Wellesley Hospital
  More Information

Responsible Party: Antje Barreveld, MD, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01968694     History of Changes
Other Study ID Numbers: 2010P002903 
Study First Received: October 21, 2013
Last Updated: October 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
endometriosis
chronic pain
intravenous lidocaine

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Lidocaine
Diphenhydramine
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2016