Trial Outcomes & Findings for A Comparison of Tumescence in Breast Reduction Surgery (NCT NCT01602692)
NCT ID: NCT01602692
Last Updated: 2020-10-05
Results Overview
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Up to 24 hours following surgery
Results posted on
2020-10-05
Participant Flow
female candidates presenting for bilateral breast reduction at the University of Wisconsin ambulatory surgery center performed by a single surgeon (Dr. Rao)
Participant milestones
| Measure |
Tumescent Solution With Dilute Epinephrine
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=20 Participants
|
41 years
n=20 Participants
|
41.5 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Mean Body Mass Index (BMI)
|
31 kg/m^2
n=20 Participants
|
33 kg/m^2
n=20 Participants
|
32 kg/m^2
n=40 Participants
|
|
Active Smoker
|
5 percentage of participants
n=20 Participants
|
15 percentage of participants
n=20 Participants
|
10 percentage of participants
n=40 Participants
|
|
History of post-op nausea
|
20 percentage of participants
n=20 Participants
|
10 percentage of participants
n=20 Participants
|
15 percentage of participants
n=40 Participants
|
|
History of previous breast surgery
|
0 percentage of participants
n=20 Participants
|
25 percentage of participants
n=20 Participants
|
12.5 percentage of participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours following surgeryAim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Post-operative Pain
End of PACU Mean Pain Level
|
5.47 score on a scale
Interval 0.0 to 10.0
|
4.47 score on a scale
Interval 1.0 to 10.0
|
|
Post-operative Pain
First 24 hrs Post-op Mean Current Pain
|
4.00 score on a scale
Interval 0.0 to 9.0
|
4.28 score on a scale
Interval 1.0 to 9.0
|
|
Post-operative Pain
First 24 hrs Post-op Mean Worst Pain
|
6.44 score on a scale
Interval 2.0 to 10.0
|
6.68 score on a scale
Interval 2.0 to 10.0
|
|
Post-operative Pain
First 24 hrs Post-op Mean Least Pain
|
2.00 score on a scale
Interval 0.0 to 4.0
|
2.53 score on a scale
Interval 0.0 to 9.0
|
PRIMARY outcome
Timeframe: Up to 24 hours following surgeryAim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Amount of Post-Operative Narcotic Medication Administered
PACU IV hydromorphone
|
0.89 mg
Interval 0.0 to 2.4
|
0.55 mg
Interval 0.0 to 2.0
|
|
Amount of Post-Operative Narcotic Medication Administered
First 24 hr Post-op oxycodone
|
32.19 mg
Interval 0.0 to 65.0
|
29.47 mg
Interval 0.0 to 80.0
|
SECONDARY outcome
Timeframe: Up to 24 hours following surgeryThe secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Post Operative Nausea and Vomiting
Nausea
|
8 episodes
|
10 episodes
|
|
Post Operative Nausea and Vomiting
Vomiting
|
2 episodes
|
4 episodes
|
SECONDARY outcome
Timeframe: Up to 24 hours following surgeryThe secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Anti-emetic / Intraoperative Medication Administered (mg)
Mean Intraoperative hydromorphone
|
0.98 mg
Interval 0.3 to 1.5
|
1.06 mg
Interval 0.0 to 2.0
|
|
Anti-emetic / Intraoperative Medication Administered (mg)
Mean Intraoperative midazolam
|
2.00 mg
Interval 2.0 to 2.0
|
1.90 mg
Interval 0.0 to 4.0
|
|
Anti-emetic / Intraoperative Medication Administered (mg)
Mean Intraoperative ketorolac
|
11.25 mg
Interval 0.0 to 30.0
|
16.50 mg
Interval 0.0 to 30.0
|
|
Anti-emetic / Intraoperative Medication Administered (mg)
Mean Intraoperative dexamethasone
|
6.40 mg
Interval 4.0 to 10.0
|
6.00 mg
Interval 0.0 to 10.0
|
|
Anti-emetic / Intraoperative Medication Administered (mg)
Mean Intraoperative ondansetron
|
3.60 mg
Interval 0.0 to 4.0
|
4.05 mg
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 24 hours following surgeryThe secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
|
131.30 micrograms
Interval 50.0 to 300.0
|
120.00 micrograms
Interval 0.0 to 200.0
|
SECONDARY outcome
Timeframe: Up to 24 hours following surgeryPopulation: Time to discharge data not was reported for all participants.
The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=14 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=13 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Time to Discharge
|
158 minutes
Standard Deviation 40.5
|
153 minutes
Standard Deviation 29.9
|
SECONDARY outcome
Timeframe: Up to 1 week following surgeryThe patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery.
Outcome measures
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 Participants
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 Participants
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Unplanned Hospital Readmission
|
0 Participants
|
0 Participants
|
Adverse Events
Tumescent Solution With Dilute Epinephrine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Tumescent Solution With Dilute Lidocaine and Epinephrine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tumescent Solution With Dilute Epinephrine
n=20 participants at risk
Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only
|
Tumescent Solution With Dilute Lidocaine and Epinephrine
n=20 participants at risk
Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • up to 24 hr post-op
|
50.0%
10/20 • up to 24 hr post-op
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • up to 24 hr post-op
|
20.0%
4/20 • up to 24 hr post-op
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place