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Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT00419276
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
University of Florida
Stryker Instruments
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: Ambulatory continuous femoral nerve block for 100 hours Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Prolonged infusion
At least 100 hours of femoral perineural ropivacaine infusion.
Procedure: Ambulatory continuous femoral nerve block for 100 hours
Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.

Placebo Comparator: Standard-of-Care
Overnight femoral perineural ropivacaine infusion followed by a femoral perineural normal saline infusion (placebo) until postoperative day 4.
Procedure: Ambulatory continuous femoral nerve block for 100 hours
Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.




Primary Outcome Measures :
  1. 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). [ Time Frame: Twice daily until hospital discharge ]

Secondary Outcome Measures :
  1. Quality-of-life as measured with the Western Ontario McMasters University questionnaire (WOMAC) up to 1 year postoperatively. [ Time Frame: preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively ]
  2. 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. [ Time Frame: Daily until 6 days postoperatively ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419276


Locations
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94705
University of California San Diego
San Diego, California, United States, 92103
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Canada, Ontario
Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
University of California, San Diego
University of Florida
Stryker Instruments
Investigators
Principal Investigator: Brian M Ilfeld, MD, MS University of California, San Diego

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, in Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00419276     History of Changes
Other Study ID Numbers: PAINfRE TKA Investigation
1K23GM077026-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Total knee arthroplasty, postoperative analgesia
Primary, unilateral, total knee arthroplasty

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents