NCT00135889

Brief Summary

The purpose of this study is to determine if putting local anesthetic-or numbing medication-through a tiny tube next to the nerves that go to the knee will improve pain control during physical therapy, and ultimately improve the results of surgery. It will also determine if patients having knee replacement surgery may receive the same or better pain control at home compared with staying in the hospital, and if this improves their experience following surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

3.5 years

First QC Date

August 24, 2005

Last Update Submit

October 7, 2009

Conditions

Pain

Keywords

Total Knee Arthroplasty secondary to osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Distance of ambulation in the afternoon following surgery

  • Time from surgical stop until three discharge criteria are met

Interventions

Femoral perineural infusionDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing unilateral, primary total knee arthropathy (TKA)
  • years of age
  • Be able to understand the possible local anesthetic-related complications, study protocol, and care of the catheter and infusion pump system and are already planning on having a perineural catheter placed for postoperative analgesia

You may not qualify if:

  • Any contraindication to femoral block/catheter
  • Any comorbidity which results in moderate or severe functional limitation (American Society of Anesthesiologists \[ASA\] physical status \>2)
  • Baseline oxygen saturation \< 96% on room air
  • Known hepatic or renal insufficiency (creatinine level \> 1.5 mg/dL)
  • Allergy to study medications (other than nonsteroidal anti-inflammatory agents \[NSAIDs\] and acetaminophen)
  • Inability to communicate with the authors
  • Morbid obesity (body mass index \[BMI\]\>40 kg/m2)
  • History of opioid abuse or chronic regular opioid use (use within the 2 weeks prior to surgery and duration of use \> 4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

La Jolla, California, 92037, United States

Location

University of Florida

Gainesville, Florida, 32610-0254, United States

Location

Related Publications (3)

  • 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, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.

    PMID: 18362603RESULT

  • Ilfeld BM, Meyer RS, Le LT, Mariano ER, Williams BA, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Maldonado RC, Gearen PF. Health-related quality of life after tricompartment knee arthroplasty with and without an extended-duration continuous femoral nerve block: a prospective, 1-year follow-up of a randomized, triple-masked, placebo-controlled study. Anesth Analg. 2009 Apr;108(4):1320-5. doi: 10.1213/ane.0b013e3181964937.

    PMID: 19299806DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

US(2)