Postoperative Pain Following Knee ArthroplastyPhase 4NCT01759277
Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
A Phase 4 study testing Experimental: Adductor Canal perineural local anesthetic infusion in people with Postoperative Pain Following Knee Arthroplasty, run by University of California, San Diego at 1 site in United States.
Trial summary
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Following Knee Arthroplasty
- What is being tested?
- Experimental: Adductor Canal perineural local anesthetic infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- primary, unilateral knee arthroplasty
- age ≥ 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours
Who cannot join
- morbid obesity as defined by a body mass index >40 (BMI=weight in kg/ [height in meters]
- chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use >4 weeks)
- history of opioid abuse
- allergy to study medications
- known renal insufficiency (creatinine > 1.5 mg/dL)
- pregnancy
- incarceration
- any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Medical Centers
San Diego, California
About this study
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.
While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.
The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
Read the detailed description
Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.
- Being tested
- Control: Femoral perineural local anesthetic infusion, Experimental: Adductor Canal perineural local anesthetic infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: Femoral perineural local anesthetic infusionDrug
The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion
Experimental: Adductor Canal perineural local anesthetic infusionDrug
The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Femoral perineural local anesthetic infusion Receives: Drug: Control: Femoral perineural local anesthetic infusion |
| Experimental | Experimental | Adductor canal perineural local anesthetic infusion Receives: Drug: Experimental: Adductor Canal perineural local anesthetic infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours Until Discharge Readiness
Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
Measured: 7 postoperative days
Secondary outcomes (6)
Time to Adequate Analgesia
The time in hours until adequate analgesia is defined as pain less than 4 on a Numeric Rating Scale of 0-10, with 0=no pain and 10=worst imaginable pain
Measured: First 7 postoperative days
Time Until Independence From Intravenous Analgesics of at Least 12 Hours
The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission)
Measured: First 7 postoperative days
Time Until Timed Up and Go Test Achieved
The timed-up-and-go (TUG) test measures the ability and speed of standing from a sitting position, walking 3 meters and returning to the original seated position independent from the assistance of healthcare personnel. This variable measured the time in hours until the patient could successfully achieve this test independently, regardless of the amount of time required.
Measured: Hours
Time Until Ambulation at Least 30 Meters
The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters)
Measured: 7 postoperative days
Pain Level
The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Measured: Postoperative Days 1-3
Opioid Consumption
Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams
Measured: Postoperative Days 0-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Following 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Summit Medical Products, Inc., Teleflex
- Responsible party
- Principal investigator, Brian M. Ilfeld, MD, MS, University of California, San Diego
- Investigators
- Brian M Ilfeld, MD, MS, Principal investigator, University California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759277
- Sponsor's protocol ID
- Adductor Canal vs Femoral
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2012
- Last updated
- 18 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
PubMed 9661552Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, Ferguson EJ, Madison SJ. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012 Sep;115(3):721-7. doi: 10.1213/ANE.0b013e318261f326. Epub 2012 Jun 28.
PubMed 22745116Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PubMed 19916251Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.
PubMed 19901788Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
PubMed 22834681Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
PubMed 21039357
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01759277
- Acronym / sponsor ID
- Adductor Canal vs Femoral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Summit Medical Products, Inc., Teleflex
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.
While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.
The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
Detailed description
Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Control: Femoral perineural local anesthetic infusionFemoral perineural local anesthetic infusion |
| Experimental | Experimental | Drug: Experimental: Adductor Canal perineural local anesthetic infusionAdductor canal perineural local anesthetic infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary, unilateral knee arthroplasty
- age ≥ 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours
Key exclusion criteria (8 listed)
- morbid obesity as defined by a body mass index >40 (BMI=weight in kg/ [height in meters]
- chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use >4 weeks)
- history of opioid abuse
- allergy to study medications
- known renal insufficiency (creatinine > 1.5 mg/dL)
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 |
|---|---|---|
| Control: Femoral perineural local anesthetic infusionThe control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion | Drug | Control |
| Experimental: Adductor Canal perineural local anesthetic infusionThe control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion | Drug | Experimental |
Primary outcome
Hours Until Discharge Readiness
Time frame: 7 postoperative days
Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
6 secondary outcomes
Time to Adequate Analgesia
Time frame: First 7 postoperative days
Time Until Independence From Intravenous Analgesics of at Least 12 Hours
Time frame: First 7 postoperative days
Time Until Timed Up and Go Test Achieved
Time frame: Hours
Time Until Ambulation at Least 30 Meters
Time frame: 7 postoperative days
Pain Level
Time frame: Postoperative Days 1-3
Opioid Consumption
Time frame: Postoperative Days 0-3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9661552Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Background: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Background: PubMed 22745116Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, Ferguson EJ, Madison SJ. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012 Sep;115(3):721-7. doi: 10.1213/ANE.0b013e318261f326. Epub 2012 Jun 28.
- Background: PubMed 19916251Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Background: PubMed 19901788Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.
- Background: PubMed 22834681Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
- Background: PubMed 21039357Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
- Individual participant dataSharing planned: No
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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 California San Diego
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 Experimental: Adductor Canal perineural local anesthetic infusion in people with Postoperative Pain Following Knee Arthroplasty, run by University of California, San Diego at 1 site 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 18 Feb 2021. 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 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.
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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hours Until Discharge Readiness (time frame: 7 postoperative days). 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 NCT01759277, which also lists 7 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 18 Feb 2021.