Arthroplasty, Replacement, Knee
Conditions
Keywords
total knee arthroplasty, femoral nerve block, local infiltration analgesia, fast track
Brief 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.
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.
Interventions
PROCEDURELIA of the posterior capsule of the knee
the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
PROCEDURELIA of the anterior capsule of the knee
the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
PROCEDURELIA of the subcutaneous tissue of the knee
the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
PROCEDUREFNB with catheter
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
Sponsors
Sint Maartenskliniek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stair Climbing Task (SCT) | one year | The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test (TUG) | 1 year | 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. |
| Six Minute Walking Test (6MWT) | 1 year | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Local Infiltration Analgesia (LIA) 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
LIA of the posterior capsule of the knee: 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 knee: 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 knee: the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure. | 40 |
| Femoral Nerve Block (FNB) 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
LIA of the posterior capsule of the knee: the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
FNB with catheter: 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 | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Local Infiltration Analgesia (LIA) | Femoral Nerve Block (FNB) | Total |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 6.9 | 66 years STANDARD_DEVIATION 6.3 | 65 years STANDARD_DEVIATION 6.6 |
| ASA physical status ASA 1 | 13 Participants | 8 Participants | 21 Participants |
| ASA physical status ASA 2 | 15 Participants | 24 Participants | 39 Participants |
| ASA physical status ASA 3 | 12 Participants | 8 Participants | 20 Participants |
| BMI | 28.4 kg/m^2 STANDARD_DEVIATION 4.2 | 30.0 kg/m^2 STANDARD_DEVIATION 4.9 | 29.2 kg/m^2 STANDARD_DEVIATION 4.6 |
| Region of Enrollment Netherlands | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 43 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 37 Participants |
| Side of surgery left | 17 Participants | 22 Participants | 39 Participants |
| Side of surgery right | 23 Participants | 18 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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.
Time frame: one year
Population: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Infiltration Analgesia (LIA) | Stair Climbing Task (SCT) | 14.3 seconds | Standard Deviation 7.1 |
| Femoral Nerve Block (FNB) | Stair Climbing Task (SCT) | 13.8 seconds | Standard Deviation 4.7 |
Secondary
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.
Time frame: 1 year
Population: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Infiltration Analgesia (LIA) | Six Minute Walking Test (6MWT) | 489 meters | Standard Deviation 71 |
| Femoral Nerve Block (FNB) | Six Minute Walking Test (6MWT) | 505 meters | Standard Deviation 84 |
Secondary
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.
Time frame: 1 year
Population: One patient from group FNB was excluded due to revision surgery of the knee; one patient from group FNB withdrew from follow up due to the development of a malignancy. One patient in group FNB and three patients in group LIA were excluded due to TKA of the contralateral knee. In group LIA one patient withdrew from follow up due to the development of a severe eye disorder requiring intensive treatment. One patient from group FNB was unable to perform the 6MWT due to severe backache.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Infiltration Analgesia (LIA) | Timed Up and Go Test (TUG) | 7.8 seconds | Standard Deviation 1.9 |
| Femoral Nerve Block (FNB) | Timed Up and Go Test (TUG) | 7.6 seconds | Standard Deviation 1.2 |