NCT00419276

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

January 4, 2007

Last Update Submit

September 27, 2016

Conditions

Total Knee Arthroplasty

Keywords

Total knee arthroplasty, postoperative analgesiaPrimary, unilateral, total knee arthroplasty

Outcome Measures

Primary Outcomes (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).

    Twice daily until hospital discharge

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Prolonged infusion

EXPERIMENTAL

At least 100 hours of femoral perineural ropivacaine infusion.

Procedure: Ambulatory continuous femoral nerve block for 100 hours

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

Interventions

Ambulatory continuous femoral nerve block for 100 hoursPROCEDURE

Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.

Prolonged infusionStandard-of-Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (2)

  • 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. doi: 10.1213/01.ane.0000189562.86969.9f.

    PMID: 16368810BACKGROUND

  • Ilfeld BM, Shuster JJ, Theriaque DW, Mariano ER, Girard PJ, Loland VJ, Meyer S, Donovan JF, Pugh GA, Le LT, Sessler DI, Ball ST. Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):116-20. doi: 10.1097/aap.0b013e3182052505.

    PMID: 21425510DERIVED

Study Officials

  • Brian M Ilfeld, MD, MS

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology, in Residence

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

CA(1)US(3)