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NCT03305666 · ClinicalTrials.gov registry record · Phase 4
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
A Phase 4 study of Opioid Dependence and Anesthesia, Local, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03305666 is a Phase 4 study of Opioid Dependence and Anesthesia, Local that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 36 participants, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03305666, a Phase 4 study of Opioid Dependence and Anesthesia, Local, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but are subject to a wide array of limitations. A more directed therapy with liposomal bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.
Conditions Studied
Interventions
- DRUG Liposomal bupivacaine injection
- DRUG Bupivacaine indwelling catheter
Study Locations (1)
Colorado
- Denver Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2021-01-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03305666
The ClinicalTrials.gov registry entry for NCT03305666 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (77% lower). The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Opioid Dependence appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine injection is the first listed.
NCT03305666 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03305666 about?
NCT03305666 is a clinical study titled "Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures". Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependenc...
What is the current status of trial NCT03305666?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2017-10-05. Estimated completion is 2021-01-31.
What conditions does trial NCT03305666 study?
This clinical trial studies the following conditions: Opioid Dependence, Anesthesia, Local, Rib Fractures, Surgical Procedure, Unspecified, Nerve Pain.
What interventions are being tested in trial NCT03305666?
The interventions under investigation include: Liposomal bupivacaine injection (DRUG), Bupivacaine indwelling catheter (DRUG).
Who is sponsoring clinical trial NCT03305666?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03305666 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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