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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00419276
• Date of registration: 04/01/2007
• Primary sponsor: National Institute of General Medical Sciences (NIGMS)
• Public title: Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Replacement
• Scientific title: Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Arthroplasty: A Multicenter, Randomized, Triple-Masked, Placebo-Controlled Investigation
• Date of first enrolment: April 2007
• Target sample size: 81
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00419276
• 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

Countries of recruitment

Canada, United States

Contacts

• Name: Brian M Ilfeld, MD, MS
• Affiliation: University of California, San Diego

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Total Knee Arthroplasty

Intervention(s)

Procedure: Ambulatory continuous femoral nerve block for 100 hours

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

1 K23 GM077026-01A1

PAINfRE TKA Investigation

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stryker Instruments

University of California, San Diego

University of Florida