Phase 2
N=47
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02525718 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Quality of Recovery Score — 165; 169 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Saline (Drug); 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery Score |
165; 169 | — |
| SECONDARY Pain Score Using 10-point Visual Analog Scale (VAS) |
4; 4 | — |
| SECONDARY Opioid Consumption |
114; 92 | — |
| SECONDARY Length of Hospital Stay |
1; 1 | — |
Summary
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
Eligibility Criteria
Inclusion Criteria
- Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete.
Exclusion Criteria
- Patients under the age of 18, or over the age of 79
- Allergy to local anesthetics or corticosteroids
- Patients with history of chronic pain or with chronic use of opioid analgesics
- Patients with history of lung disease or prior anterior thoracotomy or median sternotomy
Data sourced from ClinicalTrials.gov (NCT02525718). 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.