Overview

This trial is active, not recruiting.

Conditions pain, postoperative, postoperative nausea and vomiting
Treatments tumescent solution with dilute lidocaine and epinephrine, tumescent solution with dilute epinephrine
Sponsor University of Wisconsin, Madison
Start date August 2012
End date October 2015
Trial size 40 participants
Trial identifier NCT01602692, 2011-0543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
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.
tumescent solution with dilute epinephrine
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
(Active Comparator)
Subjects 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)

Primary Outcomes

Measure
Post-operative Pain
time frame: Up to 24 hours following surgery.

Secondary Outcomes

Measure
Post operative nausea and vomiting
time frame: Up to 24 hours following surgery
Time to Discharge
time frame: Up to 24 hours following surgery
Unplanned Hospital Readmission
time frame: Up to 1 week following surgery

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title A Comparison of Tumescence in Breast Reduction Surgery
Principal investigator Venkat K Rao, M.D. M.B.A
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.