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

Total Knee Arthroplasty Clinical Trial

Official title:

A Pilot Study of the Feasibility of Early Discharge After Total Knee Arthroplasty Using a Femoral Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659087
• Other study ID #: J-3224
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2008
• Last updated: August 2, 2016
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2016
• Source: Edmonton Civic Employees Research Fund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Femoral Block
Those receiving femoral block postoperatively

Other:
• Usual Care
Those receiving only usual pain management postoperatively

Locations

Country	Name	City	State
Canada	University of Alberta Hospitals	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Edmonton Civic Employees Research Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee flexion		at hospital discharge or day 4 postoperatively, whichever is earlier	No
Secondary	pain		daily in hospital, 2 weeks, 6 weeks, 12 weeks	No
Secondary	length of hospital stay		during hospitalization	No
Secondary	nausea/vomiting		during hospitalization	No
Secondary	participation in rehabilitation		day of surgery	No