Arthritis Clinical Trial
Official title:
Evaluation of the Efficacy of Exparel Delivered Into the Posterior Capsule During Knee Replacement
Verified date | October 2015 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Maimonides Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side effects of analgesia | Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritus, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain | first 3 days | Yes |
Primary | Subjective pain | Subject reported postsurgical pain (using an 11-point numeric rating scale) during the hospital stay and after discharge. | First 3 days | No |
Secondary | Analgesic use | Date, time, amount, and route of all opioid and non-opioid analgesics administered | First 3 days | No |
Secondary | Subject satisfaction | Overall subject satisfaction with postsurgical pain control (using a 5-point Likert scale) at the time of hospital discharge and at the last assessment 10±5 days after surgery. | 10 days +/- 5 days | No |
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