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NCT02679560
Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Phase 2 trial testing Liposomal Bupivacaine in Femoral Fractures in 3 participants. Terminated before completion.
1 November 2019
Quick facts
| Lead sponsor | Ian Elliott Brown |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 1 October 2017 |
| Primary completion | 1 November 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Liposomal Bupivacaine — full drug profile →
- Ropivacaine HCL
Conditions studied
- Femoral Fractures — all drugs for Femoral Fractures →
Sponsor
Ian Elliott Brown
Who can join
Adults 18 to 70, any sex, with Femoral Fractures. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected for the duration of the participant's hospital stay up to 96 hours.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (14 terms — click to expand)
| Reaction | System | Liposomal Bupivacaine | Ropivacaine HCL |
|---|---|---|---|
| Mild edema | Blood and lymphatic system disorders | — | — |
| mild muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| hallucination | Psychiatric disorders | — | — |
| pruritus | Skin and subcutaneous tissue disorders | — | — |
| diaphoresis | Nervous system disorders | — | — |
| urinary retention | Renal and urinary disorders | — | — |
| fever | Immune system disorders | — | — |
| elevated systolic blood pressure | Blood and lymphatic system disorders | — | — |
| tachypnea | Respiratory, thoracic and mediastinal disorders | — | — |
| tachycardia | Cardiac disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| moderate orthostatic hypotension | Nervous system disorders | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
Data from ClinicalTrials.gov NCT02679560 adverse events section.
Sponsor's own description
This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02679560
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05177991 — Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs · EARLY_PHASE1 · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02679560 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ian Elliott Brown
- Last refreshed: 21 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02679560.
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