A Comparison of Tumescence in Breast Reduction Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Tumescence in Breast Reduction Surgery

Conditions
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Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Tumescent solution with dilute lidocaine and epinephrine
* Drug: Tumescent Solution with dilute epinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tumescent solution with dilute epinephrine<br>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<br>* Tumescent Solution containing dilute epinephrine (1:1,000,000) only<br>|
| Active Comparator: Tumescent solution with dilute lidocaine and epinephrine<br>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<br>* Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain | 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. | Up to 24 hours following surgery | 
| Amount of Post-Operative Narcotic Medication Administered | Aim 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. | Up to 24 hours following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Nausea and Vomiting | The 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. | Up to 24 hours following surgery | 
| Anti-emetic / Intraoperative Medication Administered (mg) | The 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. | Up to 24 hours following surgery | 
| Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) | The 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. | Up to 24 hours following surgery | 
| Time to Discharge | 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. | Up to 24 hours following surgery | 
| Unplanned Hospital Readmission | 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. | Up to 1 week following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge