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Effects of Intravenous Lidocaine on Endometriosis Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968694
First Posted: October 24, 2013
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Antje Barreveld, MD, Brigham and Women's Hospital
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (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 Antje Barreveld, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Visual Analogue Scale (VAS) [ Time Frame: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion) ]

    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)



Secondary Outcome Measures:
  • Change in Short Form McGill Pain Questionnaire 2 [ Time Frame: 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion) ]

    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)


  • Change in Brief Pain Inventory (BPI): Pain on Average [ Time Frame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) ]

    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)


  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) ]

    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)



Enrollment: 20
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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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 mexiletene
  • Having or showing signs and symptoms of liver disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968694


Locations
United States, Massachusetts
Brigham and Women's Hospital Pain Management Center
Boston, Massachusetts, United States, 02467
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
First Submitted: October 21, 2013
First Posted: October 24, 2013
Results First Submitted: May 11, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017

Keywords provided by Antje Barreveld, MD, 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