Phase 4
N=40
A Comparison of Tumescence in Breast Reduction Surgery
Pain, Postoperative · Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01602692 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Post-operative Pain — 5.47; 4.47; 4.00; 4.28 score on a scale — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tumescent solution with dilute lidocaine and epinephrine (Drug); Tumescent Solution with dilute epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain |
5.47; 4.47; 4.00; 4.28; 6.44; 6.68 | 0.24 |
| PRIMARY Amount of Post-Operative Narcotic Medication Administered |
0.89; 0.55; 32.19; 29.47 | 0.10 |
| SECONDARY Post Operative Nausea and Vomiting |
8; 10; 2; 4 | — |
| SECONDARY Anti-emetic / Intraoperative Medication Administered (mg) |
0.98; 1.06; 2.00; 1.90; 11.25; 16.50 | — |
| SECONDARY Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) |
131.30; 120.00 | — |
| SECONDARY Time to Discharge |
158; 153 | — |
| SECONDARY Unplanned Hospital Readmission |
0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01602692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.