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Selective Local Anesthesia in Breast Reconstruction
NCT02525718Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2015
- Primary completion
- Nov 2016
- Countries
- 1
- Sponsor
- Northwestern University
- Modality
- Orthosteric Ligands
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, double-blind trial of bupivacaine and dexamethasone in postoperative pain (2 arms), sponsored by Northwestern University. Primary endpoint: Quality of Recovery Score at 24 hours. Started Aug 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Saline injection
Active
0.25% bupivacaine + 4mg dexamethasone injection
03
Who it enrols
Adult patients (18-79) undergoing mastectomy with immediate tissue expander reconstruction, excluding those with chronic pain, chronic opioid use, lung disease, or prior chest surgeries.
04
Endpoints
Primary
Quality of Recovery Score
Secondary
Pain Score Using 10-point Visual Analog Scale (VAS)
Opioid Consumption
Length of Hospital Stay
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