Trial Outcomes & Findings for Efficacy Between Serratus Plane Block And Local Infiltration In Vats (NCT NCT03642457)
NCT ID: NCT03642457
Last Updated: 2020-09-30
Results Overview
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
up to 24 hours post procedure
Results posted on
2020-09-30
Participant Flow
Participant milestones
| Measure |
Serratus Plane Group
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
30
|
|
Overall Study
COMPLETED
|
35
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing data
Baseline characteristics by cohort
| Measure |
Serratus Plane Group
n=35 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=30 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.29 years
STANDARD_DEVIATION 17.24 • n=35 Participants
|
64.30 years
STANDARD_DEVIATION 11.01 • n=30 Participants
|
58.37 years
STANDARD_DEVIATION 15.60 • n=65 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=35 Participants • missing data
|
18 Participants
n=29 Participants • missing data
|
36 Participants
n=64 Participants • missing data
|
|
Sex: Female, Male
Male
|
17 Participants
n=35 Participants • missing data
|
11 Participants
n=29 Participants • missing data
|
28 Participants
n=64 Participants • missing data
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=35 Participants
|
0 Participants
n=30 Participants
|
10 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=35 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=35 Participants
|
10 Participants
n=30 Participants
|
15 Participants
n=65 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=35 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours post procedureThe amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
Outcome measures
| Measure |
Serratus Plane Group
n=35 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=30 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
Amount of Opioid Consumption
|
18.93 MME
Standard Deviation 19.16
|
13.21 MME
Standard Deviation 18.93
|
SECONDARY outcome
Timeframe: up to 24 hours post procedureTime to first dose of narcotic administration post procedure
Outcome measures
| Measure |
Serratus Plane Group
n=35 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=30 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
Time to First Dose of Narcotic Administration
|
2.86 hours
Standard Deviation 4.17
|
3.09 hours
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: average 3-4 hours post procedureThe length of stay post procedure in the PACU
Outcome measures
| Measure |
Serratus Plane Group
n=35 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=30 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
PACU Length of Stay
|
3.45 hours
Standard Deviation 2.41
|
3.05 hours
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: up to 40 hours post procedurePopulation: only those participants who required an ICU stay
The length of stay post procedure in the or ICU
Outcome measures
| Measure |
Serratus Plane Group
n=7 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=3 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
ICU Length of Stay
|
32.57 hours
Standard Deviation 28.32
|
40.00 hours
Standard Deviation 27.71
|
SECONDARY outcome
Timeframe: up to 24 hours post procedureVisual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)
Outcome measures
| Measure |
Serratus Plane Group
n=35 Participants
Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.
|
Placebo Group
n=30 Participants
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.
|
|---|---|---|
|
Visual Analogue Score (VAS)
at 6 hours
|
3.03 score on a scale
Standard Deviation 2.71
|
3.23 score on a scale
Standard Deviation 3.02
|
|
Visual Analogue Score (VAS)
baseline
|
2.31 score on a scale
Standard Deviation 3.56
|
2.80 score on a scale
Standard Deviation 3.65
|
|
Visual Analogue Score (VAS)
at 2 hours
|
3.09 score on a scale
Standard Deviation 2.85
|
3.07 score on a scale
Standard Deviation 2.57
|
|
Visual Analogue Score (VAS)
at 18 hours
|
2.17 score on a scale
Standard Deviation 2.94
|
2.17 score on a scale
Standard Deviation 2.73
|
|
Visual Analogue Score (VAS)
at 24 hours
|
1.89 score on a scale
Standard Deviation 2.26
|
1.93 score on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: up to 24 hours post procedurePopulation: Data not collected
Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)
Outcome measures
Outcome data not reported
Adverse Events
Serratus Plane Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo 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
Restriction type: LTE60