Total Knee Arthroplasty Clinical Trial
Official title:
Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Arthroplasty: A Multicenter, Randomized, Triple-Masked, Placebo-Controlled Investigation
Verified date | September 2016 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
To determine if following total knee replacement, putting local anesthetic—or numbing medication—for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital.
Status | Completed |
Enrollment | 81 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. undergoing primary, unilateral knee replacement 2. age 18 - 75 years 3. postoperative analgesic plan includes perineural local anesthetic infusion and 4. the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal. Exclusion Criteria: 1. morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2) 2. renal insufficiency (preoperative creatinine > 1.5 mg/dL) 3. chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks) 4. history of opioid abuse and 5. any comorbidity which results in moderate or severe functional limitation. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre | Toronto | Ontario |
United States | Alta Bates Summit Medical Center | Berkeley | California |
United States | University of Florida | Gainesville | Florida |
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Stryker Instruments, University of Florida |
United States, Canada,
Ilfeld BM, Gearen PF, Enneking FK, Berry LF, Spadoni EH, George SZ, Vandenborne K. Total knee arthroplasty as an overnight-stay procedure using continuous femoral nerve blocks at home: a prospective feasibility study. Anesth Analg. 2006 Jan;102(1):87-90. Erratum in: Anesth Analg. 2006 Mar;102(3):875. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time from surgical stop until patients meet three readiness-for-discharge criteria (adequate analgesia, free of intravenous opioids for 12 hours, able to ambulate at least 30 meters). | Twice daily until hospital discharge | No | |
Secondary | Quality-of-life as measured with the Western Ontario McMasters University questionnaire (WOMAC) up to 1 year postoperatively. | preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively | No | |
Secondary | In addition, we will evaluate daily pain scores; (2) daily oral and intravenous opioid requirements; (3) sleep quality and disturbances; (4) knee flexion and extension; and (5) patient satisfaction. | Daily until 6 days postoperatively | No |
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