Phase 4
Completed N=20
Evaluation Exparel Delivered in Knee Replacement
Source: ClinicalTrials.gov NCT02011464 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Subjective Pain — 3.80; 4.00; 3.44; 5.30 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief.
Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Pain |
3.80; 4.00; 3.44; 5.30; 3.50; 3.90 | — |
| SECONDARY Post-operative Narcotic Use |
4.31; 5.75 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3
- Patients undergoing knee replacement (total knee arthroplasty)
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.
Exclusion Criteria
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
- History of pre-existing neurological disorders/neuropathy
- Morbid Obesity
Data sourced from ClinicalTrials.gov (NCT02011464). 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. Informational only — not medical advice.