- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01602692
A Comparison of Tumescence in Breast Reduction Surgery
October 2, 2020 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Middleton, Wisconsin, United States, 53562
- University of Wisconsin Transformations Surgery Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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).
|
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Pain
Time Frame: Up to 24 hours following surgery
|
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
Time Frame: Up to 24 hours following surgery
|
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
Time Frame: Up to 24 hours following surgery
|
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)
Time Frame: Up to 24 hours following surgery
|
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)
Time Frame: Up to 24 hours following surgery
|
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
Time Frame: Up to 24 hours following surgery
|
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
Time Frame: Up to 1 week following surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Venkat K Rao, M.D. M.B.A, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.
- Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg. 2008 Jul;122(1):39-52. doi: 10.1097/PRS.0b013e3181774349.
- Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.
- Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. Surgery. 2004 Oct;136(4):761-9. doi: 10.1016/j.surg.2004.06.016.
- Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
- Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol. 1990 Mar;16(3):248-63. doi: 10.1111/j.1524-4725.1990.tb03961.x.
- Ostad A, Kageyama N, Moy RL. Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction. Dermatol Surg. 1996 Nov;22(11):921-7. doi: 10.1111/j.1524-4725.1996.tb00634.x.
- Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
- Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
- Christie BM, Kapur S, Kempton SJ, Hanson SE, Ma Y, Rao VK. A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery. Plast Reconstr Surg. 2017 May;139(5):1074e-1079e. doi: 10.1097/PRS.0000000000003243.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
July 1, 2014
Study Completion (ACTUAL)
July 1, 2014
Study Registration Dates
First Submitted
May 4, 2012
First Submitted That Met QC Criteria
May 17, 2012
First Posted (ESTIMATE)
May 21, 2012
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Pain, Postoperative
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Pharmaceutical Solutions
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- 2011-0543
- A539730 (Other Identifier: UW Madison)
- SMPH/SURGERY/DENT&P SRG (OTHER: UW, Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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