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A Comparison of Tumescence in Breast Reduction Surgery

NCT01602692 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-05

Study results available
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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.

Conditions

  • Pain, Postoperative
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Tumescent solution with dilute lidocaine and epinephrine

Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)

DRUG

Tumescent Solution with dilute epinephrine

Tumescent Solution containing dilute epinephrine (1:1,000,000) only

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Venkat K Rao, M.D. M.B.A · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-07-31
Completion
2014-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602692 on ClinicalTrials.gov