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Liposomal Bupivacaine vs Continuous Catheter for Rib Fractures
NCT03305666Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2017
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- Denver Health
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, open-label trial of liposomal bupivacaine in postoperative pain (2 arms), sponsored by Denver Health. Primary endpoint: Sequential Clinical Assessment of Respiratory Function Score at 5 days. Started Oct 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bupivacaine indwelling catheter
Continuous infusion of 0.25% bupivacaine via subscapular catheter.
Liposomal bupivacaine injection
Single injection of liposomal bupivacaine mixed with plain bupivacaine via VATS.
03
Who it enrols
Patients undergoing surgical stabilization of rib fractures (SSRF) at Denver Health Medical Center. Excludes patients with allergy to bupivacaine, pregnancy, incarceration, or indwelling continuous thoracic epidural analgesia.
04
Endpoints
Primary
Sequential Clinical Assessment of Respiratory Function Score
Secondary
Daily Narcotic Requirements Using Equi-analgesic Doses
Percentage of Participants Experiencing Failure of Primary Loco-Regional Analgesia
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