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

Sponsors and Collaborators:	National Institute of General Medical Sciences (NIGMS) University of Florida University of California, San Diego Stryker Instruments
Information provided by:	National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:	NCT00419276

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

MedlinePlus related topics: Knee Replacement

Drug Information available for: Sodium chloride Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	80
Study Start Date:	April 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Prolonged infusion: Experimental 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.
Standard-of-Care: Placebo Comparator 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:

undergoing primary, unilateral knee replacement
age 18 - 75 years
postoperative analgesic plan includes perineural local anesthetic infusion and
the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal.

Exclusion Criteria:

morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
renal insufficiency (preoperative creatinine > 1.5 mg/dL)
chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
history of opioid abuse and
any comorbidity which results in moderate or severe functional limitation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419276

Contacts

Contact: Brian M Ilfeld, MD, MS	(858) 657-7101	bilfeld@ucsd.edu
Contact: Edward Mariano, MD	(619) 471-9445	emariano@ucsd.edu

Locations

United States, California
University of California San Diego	Recruiting
San Diego, California, United States, 92103
Principal Investigator: Edward Mariano, MD
Alta Bates Summit Medical Center	Recruiting
Berkeley, California, United States, 94705
Principal Investigator: John Donovan, MD
United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Linda Le, MD
Canada, Ontario
Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre	Not yet recruiting
Toronto, Ontario, Canada, M4N3M5
Principal Investigator: Colin McCartney, FRCA, FRCPC

Sponsors and Collaborators

National Institute of General Medical Sciences (NIGMS)

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

PAINfRE multicenter study research investigators This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	University of California at San Diego ( Brian M. Ilfeld, MD, MS; Principal Investigator )
Study ID Numbers:	PAINfRE TKA Investigation, 1 K23 GM077026-01A1
Study First Received:	January 4, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00419276
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

Study placed in the following topic categories:

Ropivacaine

ClinicalTrials.gov processed this record on January 14, 2009