Trial Outcomes & Findings for Effects of Intravenous Lidocaine on Endometriosis Pain (NCT NCT01968694)
NCT ID: NCT01968694
Last Updated: 2017-06-07
Results Overview
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)
COMPLETED
NA
20 participants
15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)
2017-06-07
Participant Flow
Only 19 of the 20 enrolled started the study because one participant did not participate past consent.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Visit 1 (1 Day)
STARTED
|
10
|
9
|
|
Visit 1 (1 Day)
COMPLETED
|
10
|
9
|
|
Visit 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Month)
STARTED
|
10
|
9
|
|
Washout (1 Month)
COMPLETED
|
10
|
8
|
|
Washout (1 Month)
NOT COMPLETED
|
0
|
1
|
|
Visit 2 (1 Day)
STARTED
|
10
|
8
|
|
Visit 2 (1 Day)
COMPLETED
|
10
|
8
|
|
Visit 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Washout (1 Month)
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effects of Intravenous Lidocaine on Endometriosis Pain
Baseline characteristics by cohort
| Measure |
IV Lidocaine Then IV Diphenhydramine
n=10 Participants
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.
|
IV Diphenhydramine Then IV Lidocaine
n=9 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)Population: 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.
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)
Outcome measures
| Measure |
IV Lidocaine
n=18 Participants
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
|
IV Diphenhydramine
n=19 Participants
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS)
15 minutes after start of infusion change
|
-2.6 units on a scale
Interval -4.5 to -0.8
|
-0.2 units on a scale
Interval -1.0 to 0.0
|
|
Change in Visual Analogue Scale (VAS)
30 minutes after start of infusion change
|
-3.5 units on a scale
Interval -5.0 to -2.3
|
-1.5 units on a scale
Interval -2.7 to -0.1
|
|
Change in Visual Analogue Scale (VAS)
30 minutes after infusion complete change
|
-3.6 units on a scale
Interval -4.6 to -0.6
|
-1.7 units on a scale
Interval -2.7 to 0.0
|
SECONDARY outcome
Timeframe: 30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)Population: 1. participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment. 2. participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment. 3. participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment.
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)
Outcome measures
| Measure |
IV Lidocaine
n=18 Participants
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
|
IV Diphenhydramine
n=19 Participants
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
|
|---|---|---|
|
Change in Short Form McGill Pain Questionnaire 2
1 week change from BL
|
-18 units on a scale
Interval -43.0 to -4.0
|
-17 units on a scale
Interval -30.0 to -6.0
|
|
Change in Short Form McGill Pain Questionnaire 2
1 month change from BL
|
4 units on a scale
Interval -35.0 to 24.0
|
-18 units on a scale
Interval -26.0 to -11.0
|
|
Change in Short Form McGill Pain Questionnaire 2
30 minutes change from BL
|
-14.5 units on a scale
Interval -46.0 to -8.0
|
-15 units on a scale
Interval -30.0 to -4.0
|
SECONDARY outcome
Timeframe: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)Population: 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.
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)
Outcome measures
| Measure |
IV Lidocaine
n=17 Participants
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
|
IV Diphenhydramine
n=19 Participants
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI): Pain on Average
1 day change from BL
|
-2 units on a scale
Interval -3.0 to 0.0
|
0 units on a scale
Interval -2.0 to 1.0
|
|
Change in Brief Pain Inventory (BPI): Pain on Average
1 month change from BL
|
-1 units on a scale
Interval -2.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 1.0
|
|
Change in Brief Pain Inventory (BPI): Pain on Average
1 week change from BL
|
-2 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)Population: 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.
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)
Outcome measures
| Measure |
IV Lidocaine
n=18 Participants
IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
|
IV Diphenhydramine
n=19 Participants
IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Anxiety 1 day change
|
-1 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -2.0 to 0.0
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Anxiety 1 week change
|
-1 units on a scale
Interval -2.0 to -1.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Anxiety 1 month change
|
0 units on a scale
Interval -2.0 to 0.0
|
-1.0 units on a scale
Interval -2.5 to 0.0
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Depression 1 day change
|
-0.5 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -2.0 to 0.0
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Depression 1 week change
|
-1 units on a scale
Interval -2.0 to -1.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
|
Change in Hospital Anxiety and Depression Scale (HADS)
Depression 1 month change
|
-1 units on a scale
Interval -2.0 to 0.0
|
-0.5 units on a scale
Interval -3.0 to 0.0
|
Adverse Events
IV Lidocaine
IV Diphenhydramine
Washout Period After IV Lidocaine
Washout Period After IV Diphenhydramine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place