Trial Outcomes & Findings for Subcutaneous Lidocaine For Cancer-Related Pain (NCT NCT01384877)
NCT ID: NCT01384877
Last Updated: 2019-07-12
Results Overview
The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes and lasting a minimum of 7 days: 1. A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline. Or: 2. ≥30% reduction in 24-hour opioid dose.
COMPLETED
PHASE2/PHASE3
33 participants
7 days
2019-07-12
Participant Flow
One (1) participant signed the informed consent form but withdrew from the study before receiving any treatment.
Participant milestones
| Measure |
Lidocaine/Placebo
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Treatment 1
STARTED
|
17
|
15
|
|
Treatment 1
COMPLETED
|
17
|
15
|
|
Treatment 1
NOT COMPLETED
|
0
|
0
|
|
Treatment 2
STARTED
|
16
|
13
|
|
Treatment 2
COMPLETED
|
14
|
11
|
|
Treatment 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Lidocaine/Placebo
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Treatment 2
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lidocaine/Placebo
n=17 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=16 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=17 Participants
|
13 Participants
n=16 Participants
|
27 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=17 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=33 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=17 Participants
|
9 Participants
n=16 Participants
|
16 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=17 Participants
|
7 Participants
n=16 Participants
|
17 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
17 participants
n=17 Participants
|
16 participants
n=16 Participants
|
33 participants
n=33 Participants
|
|
Palliative Performance Scale
100%
|
1 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=33 Participants
|
|
Palliative Performance Scale
90-99%
|
6 Participants
n=17 Participants
|
4 Participants
n=16 Participants
|
10 Participants
n=33 Participants
|
|
Palliative Performance Scale
80-89%
|
1 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=33 Participants
|
|
Palliative Performance Scale
70-79%
|
8 Participants
n=17 Participants
|
8 Participants
n=16 Participants
|
16 Participants
n=33 Participants
|
|
Palliative Performance Scale
60-69%
|
1 Participants
n=17 Participants
|
4 Participants
n=16 Participants
|
5 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Participants were included in analysis if they completed both treatment periods and all the data was collected for both treatment periods
The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes and lasting a minimum of 7 days: 1. A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline. Or: 2. ≥30% reduction in 24-hour opioid dose.
Outcome measures
| Measure |
Lidocaine/Placebo
n=14 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=11 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
Period 1
|
1 Participants
|
2 Participants
|
|
Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
Period 2
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?
Baseline
|
2.93 score on a scale
Standard Deviation 0.59
|
2.67 score on a scale
Standard Deviation 0.65
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?
Period 1
|
2.62 score on a scale
Standard Deviation .041
|
2.52 score on a scale
Standard Deviation 0.47
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?
Period 2
|
2.52 score on a scale
Standard Deviation 0.54
|
2.40 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?
Baseline
|
1.47 score on a scale
Standard Deviation 1.36
|
1.5 score on a scale
Standard Deviation 0.8
|
|
Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?
Period 1
|
1.40 score on a scale
Standard Deviation 0.68
|
1.29 score on a scale
Standard Deviation 0.79
|
|
Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?
Period 2
|
1.43 score on a scale
Standard Deviation 1.79
|
0.95 score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?
Baseline
|
2.13 score on a scale
Standard Deviation 0.92
|
1.67 score on a scale
Standard Deviation 1.07
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?
Period 1
|
1.92 score on a scale
Standard Deviation 0.67
|
1.71 score on a scale
Standard Deviation 0.8
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?
Period 2
|
1.73 score on a scale
Standard Deviation 0.68
|
1.47 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?
Baseline
|
1.60 score on a scale
Standard Deviation 0.91
|
1.67 score on a scale
Standard Deviation 1.07
|
|
Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?
Period 1
|
1.53 score on a scale
Standard Deviation 0.72
|
1.71 score on a scale
Standard Deviation 1.06
|
|
Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?
Period 2
|
1.50 score on a scale
Standard Deviation 0.62
|
1.45 score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?
Baseline
|
0.87 score on a scale
Standard Deviation 1.06
|
1.33 score on a scale
Standard Deviation 1.07
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?
Period 1
|
1.27 score on a scale
Standard Deviation 1.04
|
1.32 score on a scale
Standard Deviation 1.10
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?
Period 2
|
1.12 score on a scale
Standard Deviation 1.06
|
1.50 score on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?
Baseline
|
1.67 score on a scale
Standard Deviation 1.05
|
1.25 score on a scale
Standard Deviation 1.14
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?
Period 1
|
1.55 score on a scale
Standard Deviation 1.00
|
1.55 score on a scale
Standard Deviation 0.97
|
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?
Period 2
|
1.46 score on a scale
Standard Deviation 0.83
|
1.23 score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?
Baseline
|
1.73 score on a scale
Standard Deviation 0.96
|
1.75 score on a scale
Standard Deviation 1.22
|
|
Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?
Period 1
|
1.73 score on a scale
Standard Deviation 0.94
|
1.52 score on a scale
Standard Deviation 1.02
|
|
Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?
Period 2
|
1.78 score on a scale
Standard Deviation 1.05
|
1.37 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?
Baseline
|
0.67 score on a scale
Standard Deviation 1.23
|
0.50 score on a scale
Standard Deviation 1.24
|
|
Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?
Period 1
|
0.65 score on a scale
Standard Deviation 1.00
|
0.77 score on a scale
Standard Deviation 0.97
|
|
Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?
Period 2
|
0.55 score on a scale
Standard Deviation 0.87
|
0.43 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: At most 6 weeks (duration of study)Population: Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
Outcome measures
| Measure |
Lidocaine/Placebo
n=15 Participants
Patient received Lidocaine in the first period followed by placebo in the second period.
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
|
Placebo (D5W)/Lidocaine
n=12 Participants
Patient received Placebo in the first period followed by Lidocaine in the second period.
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
|---|---|---|
|
Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?
Baseline
|
1.08 score on a scale
Standard Deviation 1.04
|
1.0 score on a scale
Standard Deviation 1.35
|
|
Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?
Period 1
|
1.17 score on a scale
Standard Deviation 1.44
|
1.12 score on a scale
Standard Deviation 1.29
|
|
Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?
Period 2
|
1.20 score on a scale
Standard Deviation 1.41
|
0.93 score on a scale
Standard Deviation 1.29
|
Adverse Events
Lidocaine
Placebo (D5W)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine
n=32 participants at risk
Lidocaine
Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
|
Placebo (D5W)
n=32 participants at risk
Placebo first as compared with lidocaine first
Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)
|
|---|---|---|
|
Nervous system disorders
Tingling
|
6.2%
2/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.1%
1/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Feet Swollen
|
3.1%
1/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
Nervous system disorders
Throbbing sensation from waist down
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Neck Hurts
|
3.1%
1/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
Blood and lymphatic system disorders
Blood in Urine
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Pain
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 2 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Swelling at needle site
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
|
General disorders
Redness at needle site
|
0.00%
0/32 • 21 days after each treatment, up to 6 weeks total
|
3.1%
1/32 • Number of events 1 • 21 days after each treatment, up to 6 weeks total
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place