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

This study has been completed.
Sponsor:
Collaborators:
University of Florida
University of California, San Diego
Stryker Instruments
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00419276
First received: January 4, 2007
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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 Intervention
Total Knee Arthroplasty
Procedure: Ambulatory continuous femoral nerve block for 100 hours

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Florida
University of California, San Diego
Stryker Instruments
Investigators
Principal Investigator: Brian M Ilfeld, MD, MS University of California, San Diego
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian M. Ilfeld, MD, MS; Principal Investigator, University of California at San Diego
ClinicalTrials.gov Identifier: NCT00419276     History of Changes
Other Study ID Numbers: PAINfRE TKA Investigation, 1 K23 GM077026-01A1
Study First Received: January 4, 2007
Last Updated: September 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Total knee arthroplasty, postoperative analgesia
Primary, unilateral, total knee arthroplasty

ClinicalTrials.gov processed this record on October 30, 2014