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Trial record 1 of 1 for:    NCT01968694
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Effects of Intravenous Lidocaine on Endometriosis Pain

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ClinicalTrials.gov Identifier: NCT01968694
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Antje Barreveld, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 24, 2013
Results First Submitted Date  ICMJE May 11, 2017
Results First Posted Date  ICMJE June 7, 2017
Last Update Posted Date June 7, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Numeric Pain Score [ Time Frame: Two Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intravenous Lidocaine on Endometriosis Pain
Official Title  ICMJE Effects of Intravenous Lidocaine on Endometriosis Pain
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • Drug: IV Lidocaine
  • Drug: IV diphenhydramine
Study Arms  ICMJE
  • Experimental: IV Lidocaine
    IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
    Intervention: 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
    Intervention: Drug: IV diphenhydramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
30
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968694
Other Study ID Numbers  ICMJE 2010P002903
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antje Barreveld, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Antje Barreveld, MD Brigham and Women's Hospital, Newton-Wellesley Hospital
PRS Account Brigham and Women's Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP