- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659087
Effectiveness of a Femoral Block Following Total Knee Arthroplasty (TKA)
A Pilot Study of the Feasibility of Early Discharge After Total Knee Arthroplasty Using a Femoral Nerve Block
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- University Of Alberta Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Femoral Block
Those receiving femoral block in addition to usual pain management
|
Those receiving femoral block postoperatively
|
Active Comparator: Usual Care
Those receiving only usual pain management without a femoral block
|
Those receiving only usual pain management postoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
knee flexion
Time Frame: at hospital discharge or day 4 postoperatively, whichever is earlier
|
at hospital discharge or day 4 postoperatively, whichever is earlier
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain
Time Frame: daily in hospital, 2 weeks, 6 weeks, 12 weeks
|
daily in hospital, 2 weeks, 6 weeks, 12 weeks
|
length of hospital stay
Time Frame: during hospitalization
|
during hospitalization
|
nausea/vomiting
Time Frame: during hospitalization
|
during hospitalization
|
participation in rehabilitation
Time Frame: day of surgery
|
day of surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- J-3224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Femoral Block
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Chicago Anesthesia Pain SpecialistsCompletedKnee ArthroplastyUnited States
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CHU de ReimsUnknownTotal Hip Replacement SurgeryFrance
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University of California, San FranciscoCompletedAnterior Cruciate Ligament TearUnited States
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Clinique Medipole GaronneCompletedPrimary Total Knee ArthroplastyFrance
-
University of PennsylvaniaCompletedOsteoarthritis | Total Knee Arthroplasty (TKA) | FallsUnited States
-
Stanford UniversityCompleted
-
University of HaifaWestern Galilee Hospital-NahariyaCompletedPain, Postoperative | Post Operative Pain | Knee ArthropathyIsrael
-
Thammasat UniversityCompletedPain, Postoperative | Knee Arthroscopy | Anterior Cruciate Ligament/SurgeryThailand
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McGill University Health Centre/Research Institute...UnknownTotal Knee Arthroplasty Secondary to OsteoarthritisCanada