Total Knee ArthroplastyPhase 4NCT00659087
Effectiveness of a Femoral Block Following Total Knee Arthroplasty (TKA)
A Phase 4 study testing Femoral Block in people with Total Knee Arthroplasty, run by Edmonton Civic Employees Research Fund at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Femoral Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing primary total knee arthroplasty
- English-speaking
- Preoperative knee ROM > 90 degrees
- Body Mass Index < 40
Who cannot join
- Regular preoperative opioid use
- Hepatic insufficiency
- Any contra-indications to receiving a femoral block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Femoral Block, Usual Care
- Keywords
- Total Knee, Range of Motion, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral BlockProcedure or surgery
Those receiving femoral block postoperatively
Usual CareOther
Those receiving only usual pain management postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Femoral Block | Experimental | Those receiving femoral block in addition to usual pain management Receives: Procedure: Femoral Block |
| Usual Care | Active comparator | Those receiving only usual pain management without a femoral block Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee flexion
Measured: at hospital discharge or day 4 postoperatively, whichever is earlier
Secondary outcomes (4)
pain
Measured: daily in hospital, 2 weeks, 6 weeks, 12 weeks
length of hospital stay
Measured: during hospitalization
nausea/vomiting
Measured: during hospitalization
participation in rehabilitation
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edmonton Civic Employees Research Fund
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsui, Ban / Johnston DWC, Edmonton Civic Employees Research Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659087
- Sponsor's protocol ID
- J-3224
- Status last verified
- Aug 2016
- First submitted
- 10 Apr 2008
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility of Early Discharge After Total Knee Arthroplasty Using a Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT00659087
- Acronym / sponsor ID
- J-3224
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee, Range of Motion, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Edmonton Civic Employees Research FundUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Block | Experimental | Procedure: Femoral BlockThose receiving femoral block in addition to usual pain management |
| Usual Care | Active comparator | Other: Usual CareThose receiving only usual pain management without a femoral block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing primary total knee arthroplasty
- English-speaking
- Preoperative knee ROM > 90 degrees
- Body Mass Index < 40
Key exclusion criteria (3 listed)
- Regular preoperative opioid use
- Hepatic insufficiency
- Any contra-indications to receiving a femoral block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral BlockThose receiving femoral block postoperatively | Procedure or surgery | Femoral Block |
| Usual CareThose receiving only usual pain management postoperatively | Other | Usual Care |
Primary outcome
knee flexion
Time frame: at hospital discharge or day 4 postoperatively, whichever is earlier
4 secondary outcomes
pain
Time frame: daily in hospital, 2 weeks, 6 weeks, 12 weeks
length of hospital stay
Time frame: during hospitalization
nausea/vomiting
Time frame: during hospitalization
participation in rehabilitation
Time frame: day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Femoral Block in people with Total Knee Arthroplasty, run by Edmonton Civic Employees Research Fund at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee flexion (time frame: at hospital discharge or day 4 postoperatively, whichever is earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.