NCT01602692

A Comparison of Tumescence in Breast Reduction Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower numbers of hospital readmissions than the use of tumescent solution containing only dilute epinephrine.

Detailed description

Postoperative pain is often undermanaged in surgical patients. In the outpatient surgery population, such as breast reduction surgery, postoperative pain can lead to increased narcotic use, increased nausea, surgical complications and unplanned hospital admission, in addition to patient discomfort or dissatisfaction. Tumescence is a method of infiltrating tissues, such as the breast, with solutions of very dilute lidocaine and/or very dilute epinephrine in order to provide diffuse local anesthesia, hemostasis, and tissue manipulation. Both types of solution are considered standard care and both at the University of Wisconsin, Madison. There are two main aims to this study. Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. Aim 2 of our study is to determine the effect of dilute lidocaine in tumescent solution on secondary post-operative outcomes following breast reduction surgery. The secondary outcomes that will be measured in this study include average time (minutes) spent in the postanesthesia care unit (PACU), average time (minutes) spent in Phase 2, total time (minutes) between the end of case and discharge home, occurrence of unplanned hospital admission, 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). The investigators hypothesize that tumescence with lidocaine and epinephrine will have improved post-operative pain control leading to less narcotic use during the first twenty four hours postoperatively. (Aim 1). The investigators also believe that tumescence with lidocaine and epinephrine will lead to less time spent in PACU, less time spent in Phase2, less time between the end of the case and discharge home, less occurrence of unplanned hospital admissions, less episodes of post-operative nausea and less amount of antiemetic medication used in PACU, phase 2 and the first 24 hours post-op (Aim 2). The investigators propose that such differences could play a significant role in surgical outcomes and patient satisfaction in outpatient plastic surgery.

Conditions

• Pain, Postoperative
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Tumescent solution with dilute lidocaine and epinephrine	Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
DRUG	Tumescent Solution with dilute epinephrine	Tumescent Solution containing dilute epinephrine (1:1,000,000) only

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-05-21
• Last updated: 2020-10-05
• Results posted: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study