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NCT01602692 · ClinicalTrials.gov registry record · Phase 4

A Comparison of Tumescence in Breast Reduction Surgery

A Phase 4 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target

NCT01602692: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.

NCT01602692 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01602692, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study 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.

Primary Outcome

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 medi

Interventions

  • DRUG Tumescent solution with dilute lidocaine and epinephrine
  • DRUG Tumescent Solution with dilute epinephrine

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2012-08
Est. Completion 2014-07
Phase Phase 4
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01602692 record still lists

NCT01602692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Tumescent solution with dilute lidocaine and epinephrine is the first listed.

NCT01602692 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01602692 about?

NCT01602692 is a clinical study titled "A Comparison of Tumescence in Breast Reduction Surgery". 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 ho...

What is the current status of trial NCT01602692?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2012-08. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01602692?

The interventions under investigation include: Tumescent solution with dilute lidocaine and epinephrine (DRUG), Tumescent Solution with dilute epinephrine (DRUG).

Who is sponsoring clinical trial NCT01602692?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01602692's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01602692, the US trial registry maintained by the National Library of Medicine. NCT01602692 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.