Total Knee Arthroplasty Secondary to OsteoarthritisNCT01250041
Continuous Saphenous Block Versus Continuous Femoral Block for Total Knee Arthroplasty
A study testing continuous femoral nerve block and continuous saphenous nerve block in people with Total Knee Arthroplasty Secondary to Osteoarthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty Secondary to Osteoarthritis
- What is being tested?
- continuous femoral nerve block and continuous saphenous nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis
Who cannot join
- ASA 4-5
- Abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia
- Contraindications for spinal anesthesia
- Morbid obesity
- Organ transplant
- Neuropathic pain
Show all 12Show fewer
- History of stroke or major neurological deficit
- Sensory and motor disorders in the operated limb
- Previous drug dependency
- Chronic use of opioids
- Allergy to local anesthetics
- Inability to comprehend pain assessment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal General Hospital
Montreal, Quebec, H3A 1A1
JF Asenjo, MD, 514) 934-1934 ext. 43261, jfasenjog@yahoo.com
JF Asenjo, MD
About this study
Official title: Continuous Saphenous Block Vs. Continuous Femoral Block for Total Knee Arthroplasty: Prospective, Randomized, Double Blind Study.
Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. We will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. The primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. The secondary outcome is the morphine consumption in the two groups.
- Being tested
- continuous femoral nerve block, continuous saphenous nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous femoral nerve blockProcedure or surgery
ultrasound guided femoral nerve catheter insertion.
continuous saphenous nerve blockProcedure or surgery
ultrasound guided saphenous nerve catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| femoral block | Active comparator | Not described Receives: Procedure: continuous femoral nerve block |
| saphenous block | Experimental | Not described Receives: Procedure: continuous saphenous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the functional capacity and the impact of each block on the ability to walk by measuring the distance (the 2 minute walk test) in post op day one in the two groups.
Measured: post op day one
Secondary outcomes (1)
the morphine consumption in the two groups.
Measured: post op day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty Secondary to OsteoarthritisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- JF Asenjo, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250041
- Sponsor's protocol ID
- 10-153-SDR
- Status last verified
- Nov 2010
- First submitted
- 26 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Saphenous Block Vs. Continuous Femoral Block for Total Knee Arthroplasty: Prospective, Randomized, Double Blind Study.
- ClinicalTrials.gov ID
- NCT01250041
- Acronym / sponsor ID
- 10-153-SDR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 30 Nov 2010 (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.
Strength of the Quadriceps Muscle is key to recover from Total Knee Arthroplasty. In this study we compare two techniques for pain control after total knee arthroplasty in terms of preserving the motor function (the strength of the quadriceps muscles of the thigh) which will facilitate the rehabilitation and accelerate the hospital discharge. We will use ultrasound guided technique to block either the femoral nerve in the control group or the saphenous nerve in the experimental group. The primary outcome is the functional capacity and the impact of each block on the ability to walk by measuring the distance patients are able to walk in two minutes in post operative day one in the two groups. The secondary outcome is the morphine consumption in the two groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femoral block | Active comparator | Procedure: continuous femoral nerve block |
| saphenous block | Experimental | Procedure: continuous saphenous nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject age over 18 years coming for total knee arthroplasty secondary to osteoarthritis
Key exclusion criteria (12 listed)
- ASA 4-5
- Abnormal liver enzymes, hepatic failure, renal failure and cardiac failure if they become contraindication for the use of regional anesthesia
- Contraindications for spinal anesthesia
- Morbid obesity
- Organ transplant
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 |
|---|---|---|
| continuous femoral nerve blockultrasound guided femoral nerve catheter insertion. | Procedure or surgery | femoral block |
| continuous saphenous nerve blockultrasound guided saphenous nerve catheter insertion | Procedure or surgery | saphenous block |
Primary outcome
to assess the functional capacity and the impact of each block on the ability to walk by measuring the distance (the 2 minute walk test) in post op day one in the two groups.
Time frame: post op day one
1 secondary outcome
the morphine consumption in the two groups.
Time frame: post op day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
Related trials for Total Knee Arthroplasty Secondary to Osteoarthritis
Recruiting
Preoperative Genicular Radiofrequency and Functional Outcomes After Total Knee Arthroplasty
Total Knee Arthroplasty Secondary to Osteoarthritis, 18 Years and Older
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.
JF Asenjo, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous femoral nerve block and continuous saphenous nerve block in people with Total Knee Arthroplasty Secondary to Osteoarthritis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Nov 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JF Asengo, MD ((514) 934-1934 ext. 43261, jfasenjog@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the functional capacity and the impact of each block on the ability to walk by measuring the distance (the 2 minute walk test) in post op day one in the two groups. (time frame: post op day one). 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 30 Nov 2010.