Phase 4
N=50
Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty
Intracapsular Fracture of Femur · Femoral Neck Fractures · Hip Hemiarthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT03502018 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Post-operative Pain — 3.29; 2.64 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine liposome (Drug); Saline (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Maimonides Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain |
2.71; 2.04 | — |
| PRIMARY Post-operative Pain |
2.71; 2.04 | — |
| PRIMARY Post-operative Pain |
2.71; 2.04 | — |
| PRIMARY Post-operative Pain |
2.71; 2.04 | — |
| PRIMARY Post-operative Pain |
2.71; 2.04 | — |
| SECONDARY Time to Ambulation |
1.44; 1.12 | — |
| SECONDARY Postoperative Total Morphine Equivalent |
9.98; 12.09 | — |
| SECONDARY Delirium Scale Measurements |
0; 1; 0; 0; 24; 24 | — |
| SECONDARY Length of Stay |
3.88; 3.92 | — |
Summary
This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior approach. Post-operative measures will be assessing pain, overall opiate use, delirium, time-to-ambulation and discharge status.
Eligibility Criteria
Inclusion Criteria
Men and women sixty-five years of age and older with isolated intracapsular hip fractures undergoing hemi arthroplasty through a posterior approach with the ability to consent to the study.
Exclusion Criteria
Under sixty-five years of age, extracapsular hip fracture, suffer from any form of cognitive compromise that leaves them unable to consent, or if they are treated with any surgical modality other than hip hemiarthroplasty.
Data sourced from ClinicalTrials.gov (NCT03502018). 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.