Phase 4
Completed N=40
A Comparison of Tumescence in Breast Reduction Surgery
Pain, Postoperative · Postoperative Nausea and Vomiting
Source: ClinicalTrials.gov NCT01602692 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Post-operative Pain — 5.47; 4.47; 4.00; 4.28 score on a scale — p=0.24
◆ Published Evidence
Emerging
17citations · ~2 / year
A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery.
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.
Linked Publications
-
A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.