Phase 4
N=36
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Drug Effect · Rib Fractures · Rib Trauma · Surgical Procedure, Unspecified · Pain; Catheter (Other)
Bottom Line
View on ClinicalTrials.gov: NCT03305666 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Daily Sequential Clinical Assessment of Respiratory Function (SCARF) Score — 2; 2 score on a scale — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal bupivacaine injection (Drug); Bupivacaine indwelling catheter (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Sequential Clinical Assessment of Respiratory Function (SCARF) Score |
2; 2 | 0.12 |
| SECONDARY Daily Narcotic Requirements Using Equi-analgesic Doses |
8.8; 6.5; 6.8; 4.0; 4.0; 2.6 | 0.41 |
| SECONDARY Percentage of Participants Experiencing Failure of Primary Loco-Regional Analgesia (LRA) |
18.8; 5.6 | 0.23 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing SSRF at Denver Health Medical Center
Exclusion Criteria
- Allergy or hypersensitivity to bupivacaine
- Pregnancy
- Incarceration
- Age < 18 years
- Indwelling continuous thoracic epidural analgesia
Data sourced from ClinicalTrials.gov (NCT03305666). 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.