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Effects of Intravenous Lidocaine on Endometriosis Pain

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV Lidocaine
IV diphenhydramine
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, chronic pain, intravenous lidocaine

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital Pain Management Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Lidocaine

IV diphenhydramine

Arm Description

IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes

IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes

Outcomes

Primary Outcome Measures

Change in Visual Analogue Scale (VAS)
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
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
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)
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)

Full Information

First Posted
October 21, 2013
Last Updated
May 11, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01968694
Brief Title
Effects of Intravenous Lidocaine on Endometriosis Pain
Official Title
Effects of Intravenous Lidocaine on Endometriosis Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, chronic pain, intravenous lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Lidocaine
Arm Type
Experimental
Arm Description
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
Arm Title
IV diphenhydramine
Arm Type
Placebo Comparator
Arm Description
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
IV Lidocaine
Intervention Type
Drug
Intervention Name(s)
IV diphenhydramine
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale (VAS)
Description
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)
Time Frame
15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
Secondary Outcome Measure Information:
Title
Change in Short Form McGill Pain Questionnaire 2
Description
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)
Time Frame
30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)
Title
Change in Brief Pain Inventory (BPI): Pain on Average
Description
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)
Time Frame
1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
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)
Time Frame
1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antje Barreveld, MD
Organizational Affiliation
Brigham and Women's Hospital, Newton-Wellesley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Pain Management Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

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Effects of Intravenous Lidocaine on Endometriosis Pain

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