Trial Outcomes & Findings for Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients (NCT NCT01944098)
NCT ID: NCT01944098
Last Updated: 2017-10-26
Results Overview
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
6 hours post-surgery
Results posted on
2017-10-26
Participant Flow
Participant milestones
| Measure |
Lidocaine
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=10 Participants
Patients received 2mg/kg/hr of lidocaine intraoperatively from the time of induction until the time of emergence.
|
Placebo Arm
n=10 Participants
Patients received 2mg/kg/hr of placebo (saline) intraoperatively from the time of induction until the time of emergence.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
47.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
BMI
|
46.4 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
48.3 kg/m^2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
47.5 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours post-surgeryAnalysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Outcome measures
| Measure |
Lidocaine
n=9 Participants
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
n=10 Participants
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Postoperative Pain
Resting VAS
|
3 units on a scale
Interval 0.0 to 10.0
|
4.5 units on a scale
Interval 0.0 to 8.0
|
|
Postoperative Pain
Coughing VAS
|
8 units on a scale
Interval 3.0 to 10.0
|
8 units on a scale
Interval 5.0 to 9.0
|
|
Postoperative Pain
Moving VAS
|
8 units on a scale
Interval 0.0 to 10.0
|
8 units on a scale
Interval 4.0 to 9.0
|
PRIMARY outcome
Timeframe: 12 hours post-surgeryAnalysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Outcome measures
| Measure |
Lidocaine
n=9 Participants
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
n=10 Participants
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Postoperative Pain
Resting VAS
|
3.5 units on a scale
Interval 0.0 to 9.0
|
4 units on a scale
Interval 0.0 to 6.0
|
|
Postoperative Pain
Coughing VAS
|
7 units on a scale
Interval 5.0 to 10.0
|
7 units on a scale
Interval 2.0 to 9.0
|
|
Postoperative Pain
Moving VAS
|
8 units on a scale
Interval 5.0 to 10.0
|
7 units on a scale
Interval 5.0 to 8.0
|
PRIMARY outcome
Timeframe: 18 hours post-surgeryAnalysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Outcome measures
| Measure |
Lidocaine
n=9 Participants
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
n=10 Participants
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Postoperative Pain
Moving VAS
|
6 units on a scale
Interval 4.0 to 9.0
|
7 units on a scale
Interval 4.0 to 8.0
|
|
Postoperative Pain
Resting VAS
|
2.5 units on a scale
Interval 0.0 to 9.0
|
4.5 units on a scale
Interval 0.0 to 8.0
|
|
Postoperative Pain
Coughing VAS
|
6 units on a scale
Interval 2.0 to 10.0
|
6.5 units on a scale
Interval 4.0 to 9.0
|
PRIMARY outcome
Timeframe: 24 hours post-surgeryAnalysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Outcome measures
| Measure |
Lidocaine
n=9 Participants
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
n=10 Participants
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
Postoperative Pain
Resting VAS
|
3 units on a scale
Interval 0.0 to 8.0
|
3.5 units on a scale
Interval 0.0 to 10.0
|
|
Postoperative Pain
Coughing VAS
|
8 units on a scale
Interval 2.0 to 10.0
|
5.5 units on a scale
Interval 4.0 to 10.0
|
|
Postoperative Pain
Moving VAS
|
6 units on a scale
Interval 2.0 to 10.0
|
4.5 units on a scale
Interval 4.0 to 10.0
|
Adverse Events
Lidocaine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine
n=10 participants at risk
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
Lidocaine
|
Placebo
n=10 participants at risk
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
Placebo
|
|---|---|---|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
40.0%
4/10 • Number of events 4 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
|
Injury, poisoning and procedural complications
Metallic Taste in Mouth
|
40.0%
4/10 • Number of events 4 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
10.0%
1/10 • Number of events 1 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
|
Blood and lymphatic system disorders
Significant Blood Pressure Changes
|
0.00%
0/10 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
0.00%
0/10 • Within 1 hour post-operation
The primary outcome was the presence of lidocaine toxicity symptoms at 1 hour after lidocaine infusion cessation. We defined this endpoint as numbness or a metallic taste in the tongue or mouth, dizziness, and/or lightheadedness as reported by the patient and objectively as blood pressure changes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place