A Comparison of Tumescence in Breast Reduction Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01602692
First received: May 4, 2012
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Pain, Postoperative
Postoperative Nausea and Vomiting
Drug: Tumescent solution with dilute lidocaine and epinephrine
Drug: Tumescent Solution with dilute epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparison of Tumescence in Breast Reduction Surgery

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Post-operative Pain [ Time Frame: Up to 24 hours following surgery. ] [ Designated as safety issue: No ]
    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 and the amount of narcotic medication administered (in pacu, phase 2 and upto 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.


Secondary Outcome Measures:
  • Post operative nausea and vomiting [ Time Frame: Up to 24 hours following surgery ] [ Designated as safety issue: No ]
    The secondary outcomes that will be measured in this study include 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). This data will be attained by reviewing the medical record and through the validated survey questions.

  • Time to Discharge [ Time Frame: Up to 24 hours following surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 1 week following surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tumescent solution with dilute epinephrine
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
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Active Comparator: Tumescent solution with dilute lidocaine and epinephrine
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
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602692

Contacts
Contact: Venkat K Rao, M.D. M.B.A. rao@surgery.wisc.edu
Contact: Sahil K Kapur, M.D. skapur@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin Transformations Surgery Center Recruiting
Middleton, Wisconsin, United States, 53562
Contact: Venkat K Rao, M.D. M.B.A       rao@surgery.wisc.edu   
Contact: Sahil K Kapur, M.D.       skapur@uwhealth.org   
Principal Investigator: Venkat K Rao, M.D. M.B.A         
Sub-Investigator: Sahil K Kapur, M.D.         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Venkat K Rao, M.D. M.B.A University of Wisconsin Hospital and Clinics
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01602692     History of Changes
Other Study ID Numbers: 2011-0543
Study First Received: May 4, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Pain, postoperative
Postoperative Nausea and Vomiting
Patient Readmission
Time to Discharge

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Pain, Postoperative
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Pain
Pharmaceutical Solutions
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on September 18, 2014