Trial Outcomes & Findings for Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery (NCT NCT04995497)
NCT ID: NCT04995497
Last Updated: 2025-04-09
Results Overview
To assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. Cumulative opioid usage amounts required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
48 hours post surgical intervention
Results posted on
2025-04-09
Participant Flow
Participant milestones
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
Sham block procedure (catheter will be taped to subjects skin). Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours after sham catheter placement.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=36 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=34 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
Total
n=70 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
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
65.36 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
67.94 years
STANDARD_DEVIATION 8.28 • n=7 Participants
|
66.61 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours post surgical interventionTo assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. Cumulative opioid usage amounts required to provide relief during the first 48 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=30 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=30 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-Cumulative First 48 Hours
|
80.2 Morphine Milligram Equivalents
Interval 39.45 to 122.98
|
54.9 Morphine Milligram Equivalents
Interval 30.88 to 100.83
|
PRIMARY outcome
Timeframe: 48 hours post surgical interventionUsing a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as median and interquartile range.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=16 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=18 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Compare Pain Score Reported by Subject 48 Hours Postoperatively
|
3 scored on a scale
Interval 0.25 to 3.75
|
2 scored on a scale
Interval 0.0 to 3.25
|
SECONDARY outcome
Timeframe: First 24 hours post surgical interventionTo assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief during the first 24 hours will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=30 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=30 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-0 to 24 Hours Post Surgical Intervention
|
49.78 Morphine Milligram Equivalents
Interval 29.52 to 72.57
|
39.00 Morphine Milligram Equivalents
Interval 24.9 to 77.14
|
SECONDARY outcome
Timeframe: From 24 to 48 hours post surgical interventionTo assess if either route (IV or ESP catheter) of lidocaine provided maximal pain relief when compared to its counterpart, the type and amount of medication provided the subject will be recorded. The opioid amounts required to provide relief 24 and 48 hours post surgical intervention will be tabulated in morphine equivalents. A comparison will be made between the two route to see if one route is optimal over the other. The variables will be presented as median and interquartile range.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=30 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=30 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Quantitate the Amount of Opioid Medication Required to Provide Pain Relief-24 to 48 Hours Post Surgical Intervention
|
24.5 Morphine Milligram Equivalents
Interval 13.32 to 48.75
|
22.5 Morphine Milligram Equivalents
Interval 7.5 to 37.7
|
SECONDARY outcome
Timeframe: 24 hours post surgical interventionUsing a Numeric Rating Scale, patients are asked to report their pain on a scale of 0 to 10 with 0 being no pain and 10 is the most imaginable. The variables will be presented as Median and interquartile range.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=18 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=23 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Pain Score at 24 Hours Postoperatively
|
3.5 Scored on a scale 0-10
Interval 3.0 to 6.0
|
5.0 Scored on a scale 0-10
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 24 hours post interventionAll subjects will receive lidocaine via intravenous administration or through erector spinae plane block bilateral catheters. Arterial plasma levels monitoring the concentration of lidocaine will be checked at regular intervals. The number of subjects who reach levels above 5 micrograms/milliliter at the 24-hour timepoint will be reported.
Outcome measures
| Measure |
Erector Spinae Plane Block-Administration of Lidocaine
n=28 Participants
Bilateral ultrasound guided erector spinae plane catheter placement for the administration of lidocaine. Dose will be 2 mg/kg ideal body weight. Bolus will be divided equally between the two ESP catheters. This is followed by lidocaine infusion via ESP catheter at 2 mg/kg/hr for 48 hours after catheter placement.
Administration of Lidocaine Post Cardiac Surgery via ESP Catheter: Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
|
Intravenous-Administration of Lidocaine
n=27 Participants
Subject will receive a bolus of lidocaine at 2 mg/kg ideal body weight. This is followed by lidocaine infusion via intravenous route at 2 mg/kg/hr for 48 hours.
Intravenous Administration of Lidocaine Post Cardiac Surgery: Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
|
|---|---|---|
|
Quantify the Number of Subjects Who Had Lidocaine Plasma Levels Greater Than 5 Micrograms/Milliliter.
|
2 Participants
|
4 Participants
|
Adverse Events
Erector Spinae Plane Block-Administration of Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous-Administration of Lidocaine
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