A Comparison of Tumescence in Breast Reduction Surgery
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|ClinicalTrials.gov Identifier: NCT01602692|
Recruitment Status : Unknown
Verified October 2015 by University of Wisconsin, Madison.
Recruitment status was: Active, not recruiting
First Posted : May 21, 2012
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Postoperative Nausea and Vomiting||Drug: Tumescent solution with dilute lidocaine and epinephrine Drug: Tumescent Solution with dilute epinephrine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparison of Tumescence in Breast Reduction Surgery|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Active Comparator: Tumescent solution with dilute epinephrine
Subjects in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Drug: Tumescent Solution with dilute epinephrine
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Active Comparator: Tumescent solution with dilute lidocaine and epinephrine
Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Drug: 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 [ Time Frame: Up to 24 hours following surgery. ]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 and the amount of narcotic medication administered (in pacu, phase 2 and upto 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
- Post operative nausea and vomiting [ Time Frame: Up to 24 hours following surgery ]The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis) and amount of anti-emetic medication used in pacu, phase 2 and the first 24 hours post-op. (mg). This data will be attained by reviewing the medical record and through the validated survey questions.
- Time to Discharge [ Time Frame: Up to 24 hours following surgery ]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.
- Unplanned Hospital Readmission [ Time Frame: Up to 1 week following surgery ]The 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602692
|United States, Wisconsin|
|University of Wisconsin Transformations Surgery Center|
|Middleton, Wisconsin, United States, 53562|
|Principal Investigator:||Venkat K Rao, M.D. M.B.A||University of Wisconsin, Madison|