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Effects of Intravenous Lidocaine on Endometriosis Pain

This study has been completed.
Information provided by (Responsible Party):
Antje Barreveld, MD, Brigham and Women's Hospital Identifier:
First received: October 21, 2013
Last updated: October 5, 2016
Last verified: October 2016

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
Drug: IV Lidocaine
Drug: IV diphenhydramine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Short Form McGill Pain Questionnaire 2 [ Time Frame: Two Months ]
  • Brief Pain Inventory [ Time Frame: Two Months ]
  • Hospital Anxiety and Depression Scale [ Time Frame: Two Months ]

Enrollment: 18
Study Start Date: December 2010
Study Completion Date: June 2016
Primary Completion Date: June 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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01968694

United States, Massachusetts
Brigham and Women's Hospital Pain Management Center
Boston, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
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 Identifier: NCT01968694     History of Changes
Other Study ID Numbers: 2010P002903
Study First Received: October 21, 2013
Last Updated: October 5, 2016

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

Additional relevant MeSH terms:
Genital Diseases, Female
Anesthetics, Local
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
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents
Dermatologic Agents processed this record on April 26, 2017