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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Lidocaine | Experimental | IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes |
|
| IV diphenhydramine | Placebo Comparator | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Lidocaine | Drug |
| ||
| IV diphenhydramine |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antje Barreveld, MD | Brigham and Women's Hospital, Newton-Wellesley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital Pain Management Center | Boston | Massachusetts | 02467 | United States |
Only 19 of the 20 enrolled started the study because one participant did not participate past consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Lidocaine Then IV Diphenhydramine | 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. |
| FG001 | IV Diphenhydramine Then IV Lidocaine | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes. IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (1 Day) |
| |||||||||||||
| Washout (1 Month) |
| |||||||||||||
| Visit 2 (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Lidocaine Then IV Diphenhydramine | 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. |
| BG001 | IV Diphenhydramine Then IV Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started. 3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete. | Posted | Median | Inter-Quartile Range | units on a scale | 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Lidocaine | IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antje M Barreveld | Brigham & Women's Hospital | 617-243-6298 | abarreveld@partners.org |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion) |
| 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) | 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) |
| 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) | 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) |
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| NOT COMPLETED |
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IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes. IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
| OG001 | IV Diphenhydramine | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes |
|
|
| Secondary | 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) |
| Posted | Median | Inter-Quartile Range | units on a scale | 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion) |
|
|
|
| Secondary | 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) | In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month. | Posted | Median | Inter-Quartile Range | units on a scale | 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) |
|
|
|
| Secondary | 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) | In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month. | Posted | Median | Inter-Quartile Range | units on a scale | 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | IV Diphenhydramine | IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes | 0 | 19 | 0 | 19 |
| EG002 | Washout Period After IV Lidocaine | Washout period after IV Lidocaine before IV diphenhydramine | 0 | 10 | 0 | 10 |
| EG003 | Washout Period After IV Diphenhydramine | Washout period after IV diphenhydramine before IV Lidocaine | 0 | 8 | 0 | 8 |
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| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 1 week change from BL |
|
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| 1 month change from BL |
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| 1 week change from BL |
|
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| 1 month change from BL |
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| Anxiety 1 week change |
|
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| Anxiety 1 month change |
|
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| Depression 1 day change |
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| Depression 1 week change |
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| Depression 1 month change |
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