Trial Outcomes & Findings for Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery (NCT NCT03824808)
NCT ID: NCT03824808
Last Updated: 2023-10-25
Results Overview
10-cm Visual Analog Scale (VAS), score of 0 "no pain" to a score of 10 "worst pain ever"
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
Results posted on
2023-10-25
Participant Flow
Participant milestones
| Measure |
Treatment Group
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery
Baseline characteristics by cohort
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.Population: Patients were discharged at different times post operatively, dependent on the procedure performed and post operative pain management. Some patients were discharged before 24 hours post operatively.
10-cm Visual Analog Scale (VAS), score of 0 "no pain" to a score of 10 "worst pain ever"
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 1 hour post operative
|
5.5 score on a scale
Standard Deviation 2.8
|
4.0 score on a scale
Standard Deviation 2.4
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 2 hours post operative
|
4.4 score on a scale
Standard Deviation 3.4
|
4.2 score on a scale
Standard Deviation 1.5
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 4 hours post operative
|
4.8 score on a scale
Standard Deviation 3.2
|
3.1 score on a scale
Standard Deviation 2.2
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 6 hours post operative
|
4.0 score on a scale
Standard Deviation 2.1
|
2.5 score on a scale
Standard Deviation 2.0
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 12 hours post operative
|
3.6 score on a scale
Standard Deviation 2.8
|
2.4 score on a scale
Standard Deviation 1.6
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 24 hours post operative
|
2.3 score on a scale
Standard Deviation 1.7
|
1.9 score on a scale
Standard Deviation 1.9
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 48 hours post operative
|
2.5 score on a scale
Standard Deviation 2.5
|
2 score on a scale
Standard Deviation 0
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 72 hours post operative
|
5 score on a scale
Standard Deviation 0
|
—
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 96 hours post operative
|
6 score on a scale
Standard Deviation 0
|
—
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain 120 hours post operative
|
5 score on a scale
Standard Deviation 0
|
—
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain on discharge
|
1 score on a scale
Standard Deviation 1
|
2 score on a scale
Standard Deviation 0
|
|
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
Pain at post operative visit
|
0.5 score on a scale
Standard Deviation 1.2
|
0.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Through study completion, assessed for first 24-hours post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.Population: The milligram morphine equivalent for oral opioid use is reported per group for 24h postop, 25-48h postop, 49-72h postop, 73-96h postop, and 97-120h postop.
Difference in opioid consumption in first 24 hours, discharge and 21 days post-operatively (morphine equivalents)
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Opioid Consumption
Milligram morphine equivalent (MME) 0-24h postop
|
22.5 Milligram Morphine Equivalent
Standard Deviation 19.4
|
12.0 Milligram Morphine Equivalent
Standard Deviation 5.4
|
|
Opioid Consumption
Milligram morphine equivalent (MME) 25-48h postop
|
26.3 Milligram Morphine Equivalent
Standard Deviation 19.8
|
21.3 Milligram Morphine Equivalent
Standard Deviation 1.8
|
|
Opioid Consumption
Milligram morphine equivalent (MME) 49-72h postop
|
7.5 Milligram Morphine Equivalent
Standard Deviation 0
|
—
|
|
Opioid Consumption
Milligram morphine equivalent (MME) 73-96h postop
|
7.5 Milligram Morphine Equivalent
Standard Deviation 0
|
—
|
|
Opioid Consumption
Milligram morphine equivalent (MME) 97-120h postop
|
7.5 Milligram Morphine Equivalent
Standard Deviation 0
|
—
|
|
Opioid Consumption
Milligram morphine equivalent (MME) prescribed at discharge for home use
|
26.8 Milligram Morphine Equivalent
Standard Deviation 13.8
|
23.0 Milligram Morphine Equivalent
Standard Deviation 7.5
|
|
Opioid Consumption
Milligram morphine equivalent (MME) used of discharge prescription
|
20.0 Milligram Morphine Equivalent
Standard Deviation 22.6
|
8.8 Milligram Morphine Equivalent
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: At participant discharge, assessed up to 14 days (+/-) 7 daysPopulation: Patients were discharged at different times, dependent on post operative recovery and pain management.
Difference in length of hospital stay determined by surgeon excluding social factors that may delay discharge
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Length of Hospital Stay
Discharged within 24 hours
|
1 Participants
|
2 Participants
|
|
Length of Hospital Stay
Discharged between 24 and 48 hours
|
6 Participants
|
7 Participants
|
|
Length of Hospital Stay
Discharged between 48 and 72 hours
|
3 Participants
|
1 Participants
|
|
Length of Hospital Stay
Discharged between 72 and 96 hours
|
0 Participants
|
0 Participants
|
|
Length of Hospital Stay
Discharged between 96 and 120 hours
|
0 Participants
|
0 Participants
|
|
Length of Hospital Stay
Discharged between 120 and 144 hours
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.Population: Patients were discharged mostly within 48 hours post operatively, and post operative follow up was not successful. This is not a reliable result.
Difference in post-operative Ileus duration
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 1 hour postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 2 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 4 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 6 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 12 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 24 hours postop
|
0 Participants
|
1 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 48h postop
|
1 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 72 hours postop
|
1 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 96 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients recorded with returned ileus at 120 hours postop
|
0 Participants
|
0 Participants
|
|
Duration of Post-operative Ileus
Total patients who did not have returned ileus on discharge
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During hospitalization, approximately 2 hours post-surgeryPopulation: Data were not captured for 9 patients in the treatment group and 8 patients in the control group.
Difference in time in the Post Anesthesia Care Unit (PACU) after surgery
Outcome measures
| Measure |
Treatment Group
n=2 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=2 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Post-operative PACU Time
|
59 Minutes
Standard Deviation 7.8
|
122.5 Minutes
Standard Deviation 53
|
SECONDARY outcome
Timeframe: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge.Difference in return of flatus after surgery
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Return of Flatus
Return of flatus 2 hours post operative
|
0 Participants
|
1 Participants
|
|
Return of Flatus
Return of flatus 4 hours post operative
|
1 Participants
|
0 Participants
|
|
Return of Flatus
Return of flatus 6 hours post operative
|
1 Participants
|
2 Participants
|
|
Return of Flatus
Return of flatus 12 hours post operative
|
5 Participants
|
2 Participants
|
|
Return of Flatus
Return of flatus 24 hours post operative
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During hospitalization regular intervals for the first 24 hours, then every 24 hours until discharge.Difference in time to out of bed to chair after surgery
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
Time to Out of Bed
Out of bed to chair 2 hours post operative
|
0 Participants
|
1 Participants
|
|
Time to Out of Bed
Out of bed to chair 4 hours post operative
|
0 Participants
|
0 Participants
|
|
Time to Out of Bed
Out of bed to chair 6 hours post operative
|
1 Participants
|
1 Participants
|
|
Time to Out of Bed
Out of bed to chair 12 hours post operative
|
2 Participants
|
1 Participants
|
|
Time to Out of Bed
Out of bed to chair 24 hours post operative
|
3 Participants
|
5 Participants
|
|
Time to Out of Bed
Out of bed to chair 48 hours post operative
|
2 Participants
|
0 Participants
|
|
Time to Out of Bed
Patients out of bed to chair only at discharge
|
0 Participants
|
1 Participants
|
|
Time to Out of Bed
Patients not recorded
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours until discharge.Population: Number of patients ambulated at 1h, 2h, 4h, 6h, 12h, 24h post-operatively, then recorded every 24h until discharge.
Difference in time to first ambulation in the hallway after surgery
Outcome measures
| Measure |
Treatment Group
n=11 Participants
Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h.
|
Control Group
n=10 Participants
Normal saline
The control group received normal saline.
|
|---|---|---|
|
First Ambulation in the Hallway
Ambulated 6 hours post operatively
|
1 Participants
|
0 Participants
|
|
First Ambulation in the Hallway
Ambulated 12 hours post operatively
|
3 Participants
|
1 Participants
|
|
First Ambulation in the Hallway
Ambulated 24 hours post operatively
|
3 Participants
|
6 Participants
|
|
First Ambulation in the Hallway
Ambulated 48 hours post operatively
|
0 Participants
|
0 Participants
|
|
First Ambulation in the Hallway
Ambulated 72 hours post operatively
|
0 Participants
|
0 Participants
|
|
First Ambulation in the Hallway
Patients who only ambulated at discharge
|
0 Participants
|
1 Participants
|
|
First Ambulation in the Hallway
Patients who did not ambulate by discharge
|
2 Participants
|
2 Participants
|
|
First Ambulation in the Hallway
Patients not recorded
|
2 Participants
|
0 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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