Clinical trial NCT01602692: A Comparison of Tumescence in Breast Reduction Surgery
Official title: A Comparison of Tumescence in Breast Reduction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Keywords: Pain, postoperative
Postoperative Nausea and Vomiting
Patient Readmission
Time to Discharge
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* all patients presenting for breast reduction surgery at the University of Wisconsin Hospital and Clinics and the University of Wisconsin Transformations Surgery Center and who do not meet any of the exclusion criteria.

Exclusion Criteria:

* Women under the age of 18 years
* Breast feeding or pregnant women
* Incarcerated women.
* Women unable to give consent because of impaired decision making ability.
* Women who have reported allergies to the substances that will be used in the study.

Primary outcomes:
measure: Post-operative Pain
timeFrame: Up to 24 hours following surgery
measure: Amount of Post-Operative Narcotic Medication Administered
timeFrame: Up to 24 hours following surgery
Secondary outcomes:
measure: Post Operative Nausea and Vomiting
timeFrame: Up to 24 hours following surgery
measure: Anti-emetic / Intraoperative Medication Administered (mg)
timeFrame: Up to 24 hours following surgery
measure: Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
timeFrame: Up to 24 hours following surgery
measure: Time to Discharge
timeFrame: Up to 24 hours following surgery
measure: Unplanned Hospital Readmission
timeFrame: Up to 1 week following surgery
Other outcomes:
Locations:
city: Middleton
country: United States
facility: University of Wisconsin Transformations Surgery Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Venkat K Rao, M.D. M.B.A
role: PRINCIPAL_INVESTIGATOR
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