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

NCT00659087 | Completed Phase 4

• 1 other identifier: J-3224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee; Range of Motion; Pain

Outcome Measures

Primary Outcomes (1)

• knee flexion

  at hospital discharge or day 4 postoperatively, whichever is earlier

Secondary Outcomes (4)

• pain

  daily in hospital, 2 weeks, 6 weeks, 12 weeks

• length of hospital stay

  during hospitalization

• nausea/vomiting

  during hospitalization

• participation in rehabilitation

  day of surgery

Study Arms (2)

Femoral Block

EXPERIMENTAL

Those receiving femoral block in addition to usual pain management

Procedure: Femoral Block

Usual Care

ACTIVE COMPARATOR

Those receiving only usual pain management without a femoral block

Other: Usual Care

Interventions

Femoral Block PROCEDURE

Those receiving femoral block postoperatively

Femoral Block

Usual Care OTHER

Those receiving only usual pain management postoperatively

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Edmonton Civic Employees Research Fund: lead

Study Sites (1)

University of Alberta Hospitals

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric and Adult Anesthesiologist, Associate Professor/Director of Clinical Research, Stollery Children's Hospital/University of Alberta Hospital

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 3, 2016

Record last verified: 2016-08

Locations

CA (1)