Arthroplasty, Replacement, KneePhase 4NCT01966263
Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block
A Phase 4 study testing LIA of the posterior capsule of the knee, LIA of the anterior capsule of the knee and LIA of the subcutaneous tissue of the knee in people with Arthroplasty, Replacement, Knee, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- LIA of the posterior capsule of the knee, LIA of the anterior capsule of the knee and LIA of the subcutaneous tissue of the knee
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to Dec 2015
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical health status I-II
- patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
- patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
- patient is scheduled for fast track protocol
- patient plans to be available fot follow-up through one year post-operative
- written informed consent
Who cannot join
- any contra-indication for locoregional anesthesia
- any contra-indication for spinal anesthesia
- traumatic osteoarthritis requiring TKA
- an active, local infection or systemic infection
- known hypersensitivity to amide-type local anesthetics
- known intolerance or contraindication for opioids, nonsteroidal antiinflammatory drugs (NSAIDs) or paracetamol
Show all 14Show fewer
- a Body Mass Index > 40 kg/m2
- inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
- scheduled for contralateral TKA within one year postoperative
- scheduled for another operation within 3 months postoperative
- physical, emotional or neurological conditions that would compromize compliance with postoperative rehabilitation and follow-up
- chronic opioid analgesic therapy
- chronic gabapentin or pregabalin analgesic therapy
- rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block
The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
Read the detailed description
For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- LIA of the posterior capsule of the knee, LIA of the anterior capsule of the knee, LIA of the subcutaneous tissue of the knee, FNB with catheter
- Keywords
- total knee arthroplasty, femoral nerve block, local infiltration analgesia, fast track
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIA of the posterior capsule of the kneeProcedure or surgery
Also called Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia
the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
LIA of the anterior capsule of the kneeProcedure or surgery
Also called Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesia
the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
LIA of the subcutaneous tissue of the kneeProcedure or surgery
Also called Naropin 0.2%, local infiltration analgesia
the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
FNB with catheterProcedure or surgery
Also called Naropin 0.2%, normal saline, femoral nerve block, continuous femoral nerve block
pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Local Infiltration Analgesia (LIA) | Active comparator | local infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee Receives: Procedure: LIA of the posterior capsule of the knee; Procedure: LIA of the anterior capsule of the knee; Procedure: LIA of the subcutaneous tissue of the knee |
| Femoral Nerve Block (FNB) | Active comparator | a femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve.
In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee Receives: Procedure: LIA of the posterior capsule of the knee; Procedure: FNB with catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stair Climbing Task (SCT)
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
Measured: one year
Secondary outcomes (2)
Timed Up and Go Test (TUG)
The TUG assesses basic mobility skill as well as strength, balance, and agility. Originally developed for frail elderly people as the "Get-Up and Go Test" in 1986, it was adapted in 1991 to include the "time" component. The TUG is used in a range of populations from children to the elderly and for many conditions, including osteoarthritis, joint arthroplasty, rheumatoid arthritis, hip fractures, stroke, vertigo, and cerebral palsy.
Measured: 1 year
Six Minute Walking Test (6MWT)
The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.
Used in many conditions, such as osteoarthritis, cardiopulmonary disease, stroke, traumatic brain injury, patients who have undergone an amputation, Parkinson's disease, and Alzheimer's disease, as well as in elderly populations and children.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionDec 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maaike Fenten, Sint Maartenskliniek
- Investigators
- Rudolf Stienstra, MD, PhD, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966263
- Sponsor's protocol ID
- 497
- Other IDs
- 2013-001008-13, NL43965.072.13
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2013
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fenten MGE, Bakker SMK, Scheffer GJ, Wymenga AB, Stienstra R, Heesterbeek PJC. Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes. Br J Anaesth. 2018 Oct;121(4):850-858. doi: 10.1016/j.bja.2018.05.069. Epub 2018 Jul 26.
PubMed 30236246
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Rehabilitation Protocol for Total Knee Arthroplasty: A Randomized Controlled Trial Comparing Local Infiltration Analgesia With Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT01966263
- Acronym / sponsor ID
- 497
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- total knee arthroplasty, femoral nerve block, local infiltration analgesia, fast track
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
Detailed description
For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track rehabilitation protocol has been developed. The literature is not yet conclusive about the optimal anesthestic technique. The optimal technique should support fast mobilization by giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is shortened. But does fast recovery lead to better functional outcome? The objective of this study is to determine whether either a femoral nerve block (FNB) or local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after one year in patients receiving a total knee arthroplasty and following a fast track rehabilitation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Infiltration Analgesia (LIA) | Active comparator | Procedure: LIA of the posterior capsule of the knee, Procedure: LIA of the anterior capsule of the knee, Procedure: LIA of the subcutaneous tissue of the kneelocal infiltration analgesia is an anesthetic technique that consists of the infiltration of operated tissue with a long acting local anesthetic during surgery to achieve postoperative pain relieve. In this study LIA of the knee will exist of: 1. local infiltration analgesia (LIA) of the posterior capsule of the knee, 2. LIA of the anterior capsule of the knee and 3. LIA of the subcutaneous tissue of the knee |
| Femoral Nerve Block (FNB) | Active comparator | Procedure: LIA of the posterior capsule of the knee, Procedure: FNB with cathetera femoral nerve block is an anaesthetic technique that consists of anesthetizing the femoral nerve proximal of the operating area to achieve numbness distal of the block puncture site. A catheter can be placed, so the nerve can be anesthetized continuously or repeatedly for post-operative pain relieve. In this study the FNB with catheter will be combined with local infiltration analgesia (LIA) of the posterior capsule of the knee |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists (ASA) physical health status I-II
- patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
- patient is planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
- patient is scheduled for fast track protocol
- patient plans to be available fot follow-up through one year post-operative
Key exclusion criteria (14 listed)
- any contra-indication for locoregional anesthesia
- any contra-indication for spinal anesthesia
- traumatic osteoarthritis requiring TKA
- an active, local infection or systemic infection
- known hypersensitivity to amide-type local anesthetics
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 |
|---|---|---|
| LIA of the posterior capsule of the kneeAlso: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesiathe surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine. | Procedure or surgery | Femoral Nerve Block (FNB), Local Infiltration Analgesia (LIA) |
| LIA of the anterior capsule of the kneeAlso: Naropin 0.2%, Adrenalin 1mg/mL, local infiltration analgesiathe surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine. | Procedure or surgery | Local Infiltration Analgesia (LIA) |
| LIA of the subcutaneous tissue of the kneeAlso: Naropin 0.2%, local infiltration analgesiathe surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure. | Procedure or surgery | Local Infiltration Analgesia (LIA) |
| FNB with catheterAlso: Naropin 0.2%, normal saline, femoral nerve block, continuous femoral nerve blockpre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours | Procedure or surgery | Femoral Nerve Block (FNB) |
Primary outcome
Stair Climbing Task (SCT)
Time frame: one year
The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
2 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: 1 year
Six Minute Walking Test (6MWT)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30236246Fenten MGE, Bakker SMK, Scheffer GJ, Wymenga AB, Stienstra R, Heesterbeek PJC. Femoral nerve catheter vs local infiltration for analgesia in fast track total knee arthroplasty: short-term and long-term outcomes. Br J Anaesth. 2018 Oct;121(4):850-858. doi: 10.1016/j.bja.2018.05.069. Epub 2018 Jul 26.
- 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.
Rudolf Stienstra, MD, PhD principal investigator
Sint Maartenskliniek
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 LIA of the posterior capsule of the knee, LIA of the anterior capsule of the knee and LIA of the subcutaneous tissue of the knee in people with Arthroplasty, Replacement, Knee, run by Sint Maartenskliniek at 1 site in Netherlands.
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 6 inclusion and 14 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 25 Jan 2023. 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 Netherlands. 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 25 Jan 2023). 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?
Stair Climbing Task (SCT) (time frame: one year). 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 NCT01966263, which also lists 1 linked publication.
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 25 Jan 2023.