An interventional study of IV Lidocaine and IV diphenhydramine in Endometriosis, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-06-07.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 20 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
Drug: IV Lidocaine
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
Drug: IV diphenhydramine
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)
Time frame: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
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)
Time frame: 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)
Time frame: 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)
Time frame: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)
| Milestone | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 9 |
| Not completed | 0 | 0 |
| Milestone | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 8 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine |
|---|---|---|
| Started | 10 | 8 |
| Completed | 10 | 8 |
| Not completed | 0 | 0 |
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)
| units on a scale | IV Lidocaine | IV Diphenhydramine |
|---|---|---|
| 15 minutes after start of infusion change | -2.6 (-4.5 to -0.8) | -0.2 (-1.0 to 0) |
| 30 minutes after start of infusion change | -3.5 (-5.0 to -2.3) | -1.5 (-2.7 to -0.1) |
| 30 minutes after infusion complete change | -3.6 (-4.6 to -0.6) | -1.7 (-2.7 to 0) |
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)
| units on a scale | IV Lidocaine | IV Diphenhydramine |
|---|---|---|
| 30 minutes change from BL | -14.5 (-46 to -8) | -15 (-30 to -4) |
| 1 week change from BL | -18 (-43 to -4) | -17 (-30 to -6) |
| 1 month change from BL | 4 (-35 to 24) | -18 (-26 to -11) |
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)
| units on a scale | IV Lidocaine | IV Diphenhydramine |
|---|---|---|
| 1 day change from BL | -2 (-3 to 0) | 0 (-2 to 1) |
| 1 week change from BL | -2 (-2 to 0) | 0 (-1 to 0) |
| 1 month change from BL | -1 (-2 to 0) | -1 (-1 to 1) |
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)
| units on a scale | IV Lidocaine | IV Diphenhydramine |
|---|---|---|
| Anxiety 1 day change | -1 (-2 to 0) | 0 (-2 to 0) |
| Anxiety 1 week change | -1 (-2 to -1) | -2 (-3 to 0) |
| Anxiety 1 month change | 0 (-2 to 0) | -1.0 (-2.5 to 0) |
| Depression 1 day change | -0.5 (-2.0 to 0) | 0 (-2 to 0) |
| Depression 1 week change | -1 (-2 to -1) | -2 (-3 to 0) |
| Depression 1 month change | -1 (-2 to 0) | -0.5 (-3 to 0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Lidocaine | — | 0/18 (0%) | 0/18 (0%) |
| IV Diphenhydramine | — | 0/19 (0%) | 0/19 (0%) |
| Washout Period After IV Lidocaine | — | 0/10 (0%) | 0/10 (0%) |
| Washout Period After IV Diphenhydramine | — | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 19 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | IV Lidocaine Then IV Diphenhydramine | IV Diphenhydramine Then IV Lidocaine | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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