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A Comparison of Tumescence in Breast Reduction Surgery

Primary Purpose

Pain, Postoperative, Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tumescent solution with dilute lidocaine and epinephrine
Tumescent Solution with dilute epinephrine
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Wisconsin Transformations Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tumescent solution with dilute epinephrine

Tumescent solution with dilute lidocaine and epinephrine

Arm Description

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.

Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 4, 2012
Last Updated
October 2, 2020
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01602692
Brief Title
A Comparison of Tumescence in Breast Reduction Surgery
Official Title
A Comparison of Tumescence in Breast Reduction Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting
Keywords
Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumescent solution with dilute epinephrine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tumescent solution with dilute lidocaine and epinephrine
Arm Type
Active Comparator
Arm Description
Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Intervention Type
Drug
Intervention Name(s)
Tumescent solution with dilute lidocaine and epinephrine
Intervention Description
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
Intervention Type
Drug
Intervention Name(s)
Tumescent Solution with dilute epinephrine
Intervention Description
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
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.
Time Frame
Up to 24 hours following surgery
Title
Amount of Post-Operative Narcotic Medication Administered
Description
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.
Time Frame
Up to 24 hours following surgery
Secondary Outcome Measure Information:
Title
Post Operative Nausea and Vomiting
Description
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.
Time Frame
Up to 24 hours following surgery
Title
Anti-emetic / Intraoperative Medication Administered (mg)
Description
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.
Time Frame
Up to 24 hours following surgery
Title
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
Description
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.
Time Frame
Up to 24 hours following surgery
Title
Time to Discharge
Description
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.
Time Frame
Up to 24 hours following surgery
Title
Unplanned Hospital Readmission
Description
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.
Time Frame
Up to 1 week following surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkat K Rao, M.D. M.B.A
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Transformations Surgery Center
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15923838
Citation
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Results Reference
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Results Reference
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PubMed Identifier
18650606
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
7500539
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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A Comparison of Tumescence in Breast Reduction Surgery

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