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Effectiveness of a Femoral Block Following Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
Information provided by:
Edmonton Civic Employees Research Fund
ClinicalTrials.gov Identifier:
NCT00659087
First received: April 10, 2008
Last updated: June 21, 2011
Last verified: February 2008
  Purpose

Hospital stays after total joint replacement surgery have been getting shorter over the past 10 years. This is mostly due to new ways to manage pain and early rehabilitation. To be able to go home safely soon after surgery, patients need to:

  • 1) have adequate pain control
  • 2) be able to move through activities of daily living on their own (using aids)

Femoral nerve block, in combination with pain medications, is one of the new treatment strategies that are currently being used at other hospitals in Canada, the United States and the United Kingdom. Nerve blocks involve a needle filled with local anesthetic into the nerve that allows the feeling of pain around the knee. With good pain management, patients will be able to more quickly bend their knee and regain the ability to walk with aids and move from sitting and lying positions to standing and walking. Once they can do these activities with adequate pain control, they can be discharged from hospital to continue recovery at home. The purpose of this study is to examine a new way of managing postoperative pain and encourage early knee flexion and mobility, while maintaining pain control for patients after total knee replacement. We believe that patients who receive the nerve block in addition to the regular pain medication will have more knee flexion at discharge and experience less pain than patients who only receive usual pain medications.


Condition Intervention Phase
Total Knee Arthroplasty
Procedure: Femoral Block
Other: Usual Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Feasibility of Early Discharge After Total Knee Arthroplasty Using a Femoral Nerve Block

Resource links provided by NLM:


Further study details as provided by Edmonton Civic Employees Research Fund:

Primary Outcome Measures:
  • knee flexion [ Time Frame: at hospital discharge or day 4 postoperatively, whichever is earlier ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain [ Time Frame: daily in hospital, 2 weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
  • nausea/vomiting [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
  • participation in rehabilitation [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Femoral Block
Those receiving femoral block in addition to usual pain management
Procedure: Femoral Block
Those receiving femoral block postoperatively
No Intervention: Usual Care
Those receiving only usual pain management without a femoral block
Other: Usual Care
Those receiving only usual pain management postoperatively

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing primary total knee arthroplasty
  • English-speaking
  • Preoperative knee ROM > 90 degrees
  • Body Mass Index < 40

Exclusion Criteria:

  • Regular preoperative opioid use
  • Hepatic insufficiency
  • Any contra-indications to receiving a femoral block
  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: NCT00659087

Locations
Canada, Alberta
University of Alberta Hospitals
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
Edmonton Civic Employees Research Fund
  More Information

No publications provided

Responsible Party: Tsui, Ban; Pediatric and Adult Anesthesiologist, Associate Professor/Director of Clinical Research,, Stollery Children's Hospital/University of Alberta Hospital,
ClinicalTrials.gov Identifier: NCT00659087     History of Changes
Other Study ID Numbers: J-3224
Study First Received: April 10, 2008
Last Updated: June 21, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Edmonton Civic Employees Research Fund:
Total Knee
Range of Motion
Pain

ClinicalTrials.gov processed this record on November 27, 2014