PainNCT00135889
Continuous Femoral Nerve Block Following Total Knee Replacement
A study testing Femoral perineural infusion in people with Pain, run by National Institute of General Medical Sciences (NIGMS) at 2 sites in United States.
Trial summary
The purpose of this study is to determine if putting local anesthetic-or numbing medication-through a tiny tube next to the nerves that go to the knee will improve pain control during physical therapy, and ultimately improve the results of surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Femoral perineural infusion
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Jul 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral, primary total knee arthropathy (TKA)
- 18-80 years of age
- Be able to understand the possible local anesthetic-related complications, study protocol, and care of the catheter and infusion pump system and are already planning on having a perineural catheter placed for postoperative analgesia
Who cannot join
- Any contraindication to femoral block/catheter
- Any comorbidity which results in moderate or severe functional limitation (American Society of Anesthesiologists [ASA] physical status >2)
- Baseline oxygen saturation < 96% on room air
- Known hepatic or renal insufficiency (creatinine level > 1.5 mg/dL)
- Allergy to study medications (other than nonsteroidal anti-inflammatory agents [NSAIDs] and acetaminophen)
- Inability to communicate with the authors
- Morbid obesity (body mass index [BMI]>40 kg/m2)
- History of opioid abuse or chronic regular opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610-0254
University of California San Diego
La Jolla, California, 92037
About this study
Official title: Improving Postoperative Rehabilitation Following Total Knee Arthroplasty With Perineural Local Anesthetic Infusion
The purpose of this study is to determine if putting local anesthetic-or numbing medication-through a tiny tube next to the nerves that go to the knee will improve pain control during physical therapy, and ultimately improve the results of surgery. It will also determine if patients having knee replacement surgery may receive the same or better pain control at home compared with staying in the hospital, and if this improves their experience following surgery.
Read the detailed description
What procedures would be done as part of your normal clinical care (even if you did 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 (IV) line to make you very sleepy. The anesthesiologist will then place a nerve block so that much of your knee (not all) will be numb. At the same time, the anesthesiologist will place a tiny tube, called a catheter, near your nerves that will be used after the surgery is over. You will still go to sleep for the surgery, but you will be much 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 be removed the morning following surgery. After your catheter was removed, you would depend on oral and IV opioids-or pain medicine-to control your surgical pain. You would go home with only oral opioids since IV opioids cannot be provided at home.
What procedures will be done only because you are participating in this research study?
From the recovery room you will go to the Clinical Research Center (CRC) which is a special part of the hospital where research is undertaken. During your stay at the CRC you will have the ability to push a button on a small infusion pump 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 IV. Each 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. However, if you have pain that is not controlled with pain pills, you will be switched back to the regular medicine to improve your comfort until the following morning. You will undergo physical therapy and following this you will be checked to see if you are ready to go home. 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 goes to the nerves of your knee. One of the study physicians will call you each night to ensure that you are comfortable for the first 7 nights after your surgery, and you will be given the phone and pager numbers of a physician available for you to contact 24 hours/day, 7 days/week. When the medicine runs out or in the fourth evening following surgery, whichever comes first, your catheter will be removed. The pump is disposable, so it can be thrown away. A physician will call you the two nights after the catheter comes out to ensure that you are comfortable.
- Conditions
- Pain
- Being tested
- Femoral perineural infusion
- Keywords
- Total Knee Arthroplasty secondary to osteoarthritis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral perineural infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance of ambulation in the afternoon following surgery
Time from surgical stop until three discharge criteria are met
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Foundation for Anesthesia Education and Research, Arrow International, Stryker Instruments, University of Florida, 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
- NCT00135889
- Sponsor's protocol ID
- 560-2003
- Other IDs
- GCRC 582, GCRC Grant RR00082
- Status last verified
- Oct 2009
- First submitted
- 24 Aug 2005
- Last updated
- 8 Oct 2009
- 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, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.
PubMed 18362603Ilfeld BM, Meyer RS, Le LT, Mariano ER, Williams BA, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Maldonado RC, Gearen PF. Health-related quality of life after tricompartment knee arthroplasty with and without an extended-duration continuous femoral nerve block: a prospective, 1-year follow-up of a randomized, triple-masked, placebo-controlled study. Anesth Analg. 2009 Apr;108(4):1320-5. doi: 10.1213/ane.0b013e3181964937.
PubMed 19299806
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Postoperative Rehabilitation Following Total Knee Arthroplasty With Perineural Local Anesthetic Infusion
- ClinicalTrials.gov ID
- NCT00135889
- Acronym / sponsor ID
- 560-2003
- Conditions
- Pain
- Keywords
- Total Knee Arthroplasty secondary to osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Collaborators
- Foundation for Anesthesia Education and Research, Arrow International, Stryker Instruments, University of Florida, University of California, San Diego
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Aug 2005 (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.
The purpose of this study is to determine if putting local anesthetic-or numbing medication-through a tiny tube next to the nerves that go to the knee will improve pain control during physical therapy, and ultimately improve the results of surgery. It will also determine if patients having knee replacement surgery may receive the same or better pain control at home compared with staying in the hospital, and if this improves their experience following surgery.
Detailed description
What procedures would be done as part of your normal clinical care (even if you did 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 (IV) line to make you very sleepy. The anesthesiologist will then place a nerve block so that much of your knee (not all) will be numb. At the same time, the anesthesiologist will place a tiny tube, called a catheter, near your nerves that will be used after the surgery is over. You will still go to sleep for the surgery, but you will be much 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 be removed the morning following surgery. After your catheter was removed, you would depend on oral and IV opioids-or pain medicine-to control your surgical pain. You would go home with only oral opioids since IV opioids cannot be provided at home.
What procedures will be done only because you are participating in this research study?
From the recovery room you will go to the Clinical Research Center (CRC) which is a special part of the hospital where research is undertaken. During your stay at the CRC you will have the ability to push a button on a small infusion pump 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 IV. Each 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. However, if you have pain that is not controlled with pain pills, you will be switched back to the regular medicine to improve your comfort until the following morning. You will undergo physical therapy and following this you will be checked to see if you are ready to go home. 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 goes to the nerves of your knee. One of the study physicians will call you each night to ensure that you are comfortable for the first 7 nights after your surgery, and you will be given the phone and pager numbers of a physician available for you to contact 24 hours/day, 7 days/week. When the medicine runs out or in the fourth evening following surgery, whichever comes first, your catheter will be removed. The pump is disposable, so it can be thrown away. A physician will call you the two nights after the catheter comes out to ensure that you are comfortable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral, primary total knee arthropathy (TKA)
- 18-80 years of age
- Be able to understand the possible local anesthetic-related complications, study protocol, and care of the catheter and infusion pump system and are already planning on having a perineural catheter placed for postoperative analgesia
Key exclusion criteria (8 listed)
- Any contraindication to femoral block/catheter
- Any comorbidity which results in moderate or severe functional limitation (American Society of Anesthesiologists [ASA] physical status >2)
- Baseline oxygen saturation < 96% on room air
- Known hepatic or renal insufficiency (creatinine level > 1.5 mg/dL)
- Allergy to study medications (other than nonsteroidal anti-inflammatory agents [NSAIDs] and acetaminophen)
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 perineural infusion | Drug | – |
Primary outcome
Distance of ambulation in the afternoon following surgery
Time from surgical stop until three discharge criteria are met
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 8 Oct 2009.
- 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.
- Results publication: PubMed 18362603Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.
- Derived from this study: PubMed 19299806Ilfeld BM, Meyer RS, Le LT, Mariano ER, Williams BA, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Maldonado RC, Gearen PF. Health-related quality of life after tricompartment knee arthroplasty with and without an extended-duration continuous femoral nerve block: a prospective, 1-year follow-up of a randomized, triple-masked, placebo-controlled study. Anesth Analg. 2009 Apr;108(4):1320-5. doi: 10.1213/ane.0b013e3181964937.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral perineural infusion in people with Pain, run by National Institute of General Medical Sciences (NIGMS) at 2 sites in United States.
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 3 inclusion and 8 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 8 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Distance of ambulation in the afternoon following surgery. The study lists 2 primary outcomes in all. 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 NCT00135889, which also lists 3 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 8 Oct 2009.