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Completed

NCT Number: NCT01968694

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital Pain Management Center

Boston, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Lidocaine

Drug

IV diphenhydramine

Drug

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2013
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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