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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: Completed Phase 4 study of Opioid Dependence and Anesthesia, Local, sponsored by Denver Health and Hospital Authority.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The SCARF score is a validated, dynamic tool that ranges from 0-4, with 0 being the best score and 4 being the worst. One point is given for each of the following four parameters: (1) respiratory rate ≥ 20 breaths per minute; (2) numeric pain score ≥ 5; (3) incentive spirometry \< 50% of predicted based upon a nomogram including sex, height, and age; (4) cough deemed inadequate to clear respiratory secretions by respiratory therapists. The parameters used to calculate the SCARF score are summed
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 |
What the finished NCT03305666 record still lists
NCT03305666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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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