Total Knee ArthroplastyNCT00419276
Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Replacement
A study testing Ambulatory continuous femoral nerve block for 100 hours in people with Total Knee Arthroplasty, run by University of California, San Diego at 4 sites in 2 countries.
Trial summary
To determine if following total knee replacement, putting local anesthetic-or numbing medication-for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Ambulatory continuous femoral nerve block for 100 hours
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2007to Aug 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing primary, unilateral knee replacement
- age 18 - 75 years
- postoperative analgesic plan includes perineural local anesthetic infusion and
- the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal.
Who cannot join
- morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
- renal insufficiency (preoperative creatinine > 1.5 mg/dL)
- chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- history of opioid abuse and
- any comorbidity which results in moderate or severe functional limitation.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Alta Bates Summit Medical Center
Berkeley, California, 94705
University of Florida
Gainesville, Florida, 32610
University of California San Diego
San Diego, California, 92103
Canada1 site
Sunnybrook Health Sciences Centre and the Holland Orthopedic and Arthritic Centre
Toronto, Ontario, M4N3M5
About this study
Official title: Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Arthroplasty: A Multicenter, Randomized, Triple-Masked, Placebo-Controlled Investigation
To determine if following total knee replacement, putting local anesthetic-or numbing medication-for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital.
Read the detailed description
- Procedures that will be done as part of your normal clinical care (even if you do not participate in this research): You will have some monitors placed (such as a blood-pressure cuff) and be given some medicines through your intravenous line to make you very sleepy. The anesthesiologist will then place a tiny tube, called a catheter, near your nerves that will be used during and following surgery. This involves carefully cleaning the immediate area in the upper thigh where the catheter will be placed, numbing the site of the catheter with local anesthetic placed just under the skin, placing a needle through the skin that is numbed to an area near where your nerves are, putting the catheter through the needle so that the tip is next to your nerves, then removing the needle leaving the catheter in place. You can still go to sleep for the surgery, but you will be more comfortable when you wake up because the numbing medicine will be working to take away much of the pain. If you are not part of this study, you would go from the recovery room to a room in the hospital for 3-5 days, and your catheter would probably be removed the morning after surgery. After removal of your catheter, you would depend on oral and intravenous pain medicine ("opioids"-like morphine) to control your surgical pain. You would go home with only oral opioids since intravenous opioids cannot be provided at home.
- Procedures that will be done only if you participate in this research study: From the recovery room you will go to the surgical ward. During your stay in the hospital you will have the ability to push a button on a small infusion pump-a little device that holds and puts the medicine through the catheter to bath your nerves in local anesthetic-to give yourself more medicine through the tube to your nerves if you have pain. If this does not help enough, you will take pain pills to help. And if this does not help enough, you will be given opioids (strong pain medicine like morphine) into your intravenous line.
- On the morning after surgery, the medicine in your little infusion pump will be replaced by either (1) more medicine, or (2) salt water, or "normal saline". The pharmacist will determine this randomly-like flipping a coin-and neither you nor the doctors/nurses caring for you will know which you have. This is to keep any of us from inadvertently/ unconsciously affecting the results of the study.
- You will undergo physical therapy and following this you will be checked to see if you are ready to go home. This will include walking in the morning and afternoon with a physical therapist. When you are ready to go home beginning on the third day after surgery, you may go home with the little infusion pump and the tube that delivers the fluid. You will be given a prescription for pain pills in case you need them for pain relief.
- One of the study investigators will call you each night to ensure that you are comfortable for the first 6 nights after your surgery, and you will be given the phone and pager numbers of your physician (anesthesiologist) available for you to contact 24 hours/day, 7 days/week. A research nurse will call you for five nights beginning the day after surgery to ask about your comfort level and other study-related information such as your satisfaction level.
- On the fourth evening following surgery your catheter will be removed. You have two options available to you to remove your catheter. You can call a physician who will talk you or your caregiver through this process over the phone--it will not hurt or bleed. Your other option is to come back to the hospital to have a health care professional remove the catheter for you. The pump, catheter and remaining fluid are disposable and will not hurt people or pets, so they will be thrown away. A physician will call you the night after the catheter comes out to ensure that you are comfortable.
- A research nurse will call you at 7 days and then 1, 2, 3, 6, and 12 months following your surgery. Each of these calls will be less than five minutes in length during which time you will be asked questions about your levels of pain, stiffness and joint functional ability. Your participation will be limited to 12 months after surgery with these phone calls.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Ambulatory continuous femoral nerve block for 100 hours
- Keywords
- Total knee arthroplasty, postoperative analgesia, Primary, unilateral, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory continuous femoral nerve block for 100 hoursProcedure or surgery
Treatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged infusion | Experimental | At least 100 hours of femoral perineural ropivacaine infusion. Receives: Procedure: Ambulatory continuous femoral nerve block for 100 hours |
| Standard-of-Care | Placebo comparator | Overnight femoral perineural ropivacaine infusion followed by a femoral perineural normal saline infusion (placebo) until postoperative day 4. Receives: Procedure: Ambulatory continuous femoral nerve block for 100 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from surgical stop until patients meet three readiness-for-discharge criteria (adequate analgesia, free of intravenous opioids for 12 hours, able to ambulate at least 30 meters).
Measured: Twice daily until hospital discharge
Secondary outcomes (2)
Quality-of-life as measured with the Western Ontario McMasters University questionnaire (WOMAC) up to 1 year postoperatively.
Measured: preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively
In addition, we will evaluate daily pain scores; (2) daily oral and intravenous opioid requirements; (3) sleep quality and disturbances; (4) knee flexion and extension; and (5) patient satisfaction.
Measured: Daily until 6 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Stryker Instruments
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, MD, MS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419276
- Sponsor's protocol ID
- PAINfRE TKA Investigation
- Other IDs
- 1K23GM077026-01A1
- Status last verified
- Sep 2016
- First submitted
- 4 Jan 2007
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ilfeld BM, Gearen PF, Enneking FK, Berry LF, Spadoni EH, George SZ, Vandenborne K. Total knee arthroplasty as an overnight-stay procedure using continuous femoral nerve blocks at home: a prospective feasibility study. Anesth Analg. 2006 Jan;102(1):87-90. doi: 10.1213/01.ane.0000189562.86969.9f.
PubMed 16368810Ilfeld BM, Shuster JJ, Theriaque DW, Mariano ER, Girard PJ, Loland VJ, Meyer S, Donovan JF, Pugh GA, Le LT, Sessler DI, Ball ST. Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):116-20. doi: 10.1097/aap.0b013e3182052505.
PubMed 21425510
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ambulatory Continuous Femoral Nerve Blocks on Readiness-for-Discharge Following Total Knee Arthroplasty: A Multicenter, Randomized, Triple-Masked, Placebo-Controlled Investigation
- ClinicalTrials.gov ID
- NCT00419276
- Acronym / sponsor ID
- PAINfRE TKA Investigation
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, postoperative analgesia, Primary, unilateral, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Florida, Stryker Instruments
- Study start
- Apr 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 Jan 2007 (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.
To determine if following total knee replacement, putting local anesthetic-or numbing medication-for five days through a tiny tube next to the nerves that go to the knee will decrease the time that patients need to spend in the hospital.
Detailed description
- Procedures that will be done as part of your normal clinical care (even if you do not participate in this research): You will have some monitors placed (such as a blood-pressure cuff) and be given some medicines through your intravenous line to make you very sleepy. The anesthesiologist will then place a tiny tube, called a catheter, near your nerves that will be used during and following surgery. This involves carefully cleaning the immediate area in the upper thigh where the catheter will be placed, numbing the site of the catheter with local anesthetic placed just under the skin, placing a needle through the skin that is numbed to an area near where your nerves are, putting the catheter through the needle so that the tip is next to your nerves, then removing the needle leaving the catheter in place. You can still go to sleep for the surgery, but you will be more comfortable when you wake up because the numbing medicine will be working to take away much of the pain. If you are not part of this study, you would go from the recovery room to a room in the hospital for 3-5 days, and your catheter would probably be removed the morning after surgery. After removal of your catheter, you would depend on oral and intravenous pain medicine ("opioids"-like morphine) to control your surgical pain. You would go home with only oral opioids since intravenous opioids cannot be provided at home.
- Procedures that will be done only if you participate in this research study: From the recovery room you will go to the surgical ward. During your stay in the hospital you will have the ability to push a button on a small infusion pump-a little device that holds and puts the medicine through the catheter to bath your nerves in local anesthetic-to give yourself more medicine through the tube to your nerves if you have pain. If this does not help enough, you will take pain pills to help. And if this does not help enough, you will be given opioids (strong pain medicine like morphine) into your intravenous line.
- On the morning after surgery, the medicine in your little infusion pump will be replaced by either (1) more medicine, or (2) salt water, or "normal saline". The pharmacist will determine this randomly-like flipping a coin-and neither you nor the doctors/nurses caring for you will know which you have. This is to keep any of us from inadvertently/ unconsciously affecting the results of the study.
- You will undergo physical therapy and following this you will be checked to see if you are ready to go home. This will include walking in the morning and afternoon with a physical therapist. When you are ready to go home beginning on the third day after surgery, you may go home with the little infusion pump and the tube that delivers the fluid. You will be given a prescription for pain pills in case you need them for pain relief.
- One of the study investigators will call you each night to ensure that you are comfortable for the first 6 nights after your surgery, and you will be given the phone and pager numbers of your physician (anesthesiologist) available for you to contact 24 hours/day, 7 days/week. A research nurse will call you for five nights beginning the day after surgery to ask about your comfort level and other study-related information such as your satisfaction level.
- On the fourth evening following surgery your catheter will be removed. You have two options available to you to remove your catheter. You can call a physician who will talk you or your caregiver through this process over the phone--it will not hurt or bleed. Your other option is to come back to the hospital to have a health care professional remove the catheter for you. The pump, catheter and remaining fluid are disposable and will not hurt people or pets, so they will be thrown away. A physician will call you the night after the catheter comes out to ensure that you are comfortable.
- A research nurse will call you at 7 days and then 1, 2, 3, 6, and 12 months following your surgery. Each of these calls will be less than five minutes in length during which time you will be asked questions about your levels of pain, stiffness and joint functional ability. Your participation will be limited to 12 months after surgery with these phone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged infusion | Experimental | Procedure: Ambulatory continuous femoral nerve block for 100 hoursAt least 100 hours of femoral perineural ropivacaine infusion. |
| Standard-of-Care | Placebo comparator | Procedure: Ambulatory continuous femoral nerve block for 100 hoursOvernight femoral perineural ropivacaine infusion followed by a femoral perineural normal saline infusion (placebo) until postoperative day 4. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing primary, unilateral knee replacement
- age 18 - 75 years
- postoperative analgesic plan includes perineural local anesthetic infusion and
- the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal.
Key exclusion criteria (5 listed)
- morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
- renal insufficiency (preoperative creatinine > 1.5 mg/dL)
- chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- history of opioid abuse and
- any comorbidity which results in moderate or severe functional limitation.
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 |
|---|---|---|
| Ambulatory continuous femoral nerve block for 100 hoursTreatment group: 100 hours of ropivacaine femoral perineural infusion. Standard-of-care group: overnight ropivacaine femoral perineural infusion followed by a normal saline infusion. | Procedure or surgery | Prolonged infusion, Standard-of-Care |
Primary outcome
The time from surgical stop until patients meet three readiness-for-discharge criteria (adequate analgesia, free of intravenous opioids for 12 hours, able to ambulate at least 30 meters).
Time frame: Twice daily until hospital discharge
2 secondary outcomes
Quality-of-life as measured with the Western Ontario McMasters University questionnaire (WOMAC) up to 1 year postoperatively.
Time frame: preoperatively, then 7 days, 1, 2, 3, 6, and 12 months postoperatively
In addition, we will evaluate daily pain scores; (2) daily oral and intravenous opioid requirements; (3) sleep quality and disturbances; (4) knee flexion and extension; and (5) patient satisfaction.
Time frame: Daily until 6 days postoperatively
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 28 Sep 2016.
- Background: PubMed 16368810Ilfeld BM, Gearen PF, Enneking FK, Berry LF, Spadoni EH, George SZ, Vandenborne K. Total knee arthroplasty as an overnight-stay procedure using continuous femoral nerve blocks at home: a prospective feasibility study. Anesth Analg. 2006 Jan;102(1):87-90. doi: 10.1213/01.ane.0000189562.86969.9f.
- Derived from this study: PubMed 21425510Ilfeld BM, Shuster JJ, Theriaque DW, Mariano ER, Girard PJ, Loland VJ, Meyer S, Donovan JF, Pugh GA, Le LT, Sessler DI, Ball ST. Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):116-20. doi: 10.1097/aap.0b013e3182052505.
- PAINfRE multicenter study research investigatorsLink provided by the sponsor.
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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.
Brian M Ilfeld, MD, MS principal investigator
University of California, San Diego
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory continuous femoral nerve block for 100 hours in people with Total Knee Arthroplasty, run by University of California, San Diego at 4 sites in 2 countries.
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 5 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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. Some participants in this study may receive a placebo. 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?
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?
The time from surgical stop until patients meet three readiness-for-discharge criteria (adequate analgesia, free of intravenous opioids for 12 hours, able to ambulate at least 30 meters). (time frame: Twice daily until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419276, which also lists 2 linked publications.
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 28 Sep 2016.