Postoperative Pain Following Knee Arthroplasty
Conditions
Brief 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. 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.
Interventions
DRUGControl: Femoral perineural local anesthetic infusion
The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion
DRUGExperimental: Adductor Canal perineural local anesthetic infusion
The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion
Sponsors
Summit Medical Products, Inc.
Teleflex
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. primary, unilateral knee arthroplasty 2. age ≥ 18 years 3. postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours
Exclusion criteria
1. morbid obesity as defined by a body mass index \>40 (BMI=weight in kg/ \[height in meters\] 2. 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) 3. history of opioid abuse 4. allergy to study medications 5. known renal insufficiency (creatinine \> 1.5 mg/dL) 6. pregnancy 7. incarceration 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hours Until Discharge Readiness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Until Independence From Intravenous Analgesics of at Least 12 Hours | First 7 postoperative days | The time in hours until no intravenous analgesics were required for at least 12 hours (without future intravenous use during admission) |
| Time Until Timed Up and Go Test Achieved | Hours | 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. |
| Time to Adequate Analgesia | First 7 postoperative days | 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 |
| Pain Level | Postoperative Days 1-3 | The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain |
| Opioid Consumption | Postoperative Days 0-3 | Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams |
| Time Until Ambulation at Least 30 Meters | 7 postoperative days | The time in hours until a patient could ambulate at least 30 meters independently (regardless of time to achieve the 30 meters) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Femoral perineural local anesthetic infusion
Active comparator: Control: Femoral perineural local anesthetic infusion: The control group will receive a femoral nerve catheter and block under ultrasound guidance with the final position of catheter posterior to the femoral nerve and lateral to the femoral artery. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. | 41 |
| Experimental Adductor canal perineural local anesthetic infusion
Experimental: Adductor Canal perineural local anesthetic infusion: The experimental group will receive an adductor canal catheter and block under ultrasound guidance with the final position of catheter between the femoral artery and nerve. Normal saline up to 10ml will be injected if necessary for hydro-dissection via the needle. The catheter will then be threaded 3-5cm past the needle tip and its location will be confirmed by a 30ml bolus of lidocaine 2% via the catheter under ultrasound visualization. The control group will receive a standardized general anesthetic with inhaled volatile anesthesia in nitrous oxide and oxygen or bupivacaine spinal anesthetic. | 39 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 7 | 67 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8 |
| Body Mass Index | 29 kg/m2 STANDARD_DEVIATION 5 | 30 kg/m2 STANDARD_DEVIATION 5 | 30 kg/m2 STANDARD_DEVIATION 5 |
| Height | 168 cm STANDARD_DEVIATION 10 | 169 cm STANDARD_DEVIATION 11 | 169 cm STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 30 Participants |
| Weight | 84 kg STANDARD_DEVIATION 16 | 87 kg STANDARD_DEVIATION 16 | 86 kg STANDARD_DEVIATION 17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 3 / 41 | 2 / 39 |
Outcome results
Primary
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.
Time frame: 7 postoperative days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Hours Until Discharge Readiness | 61 hours |
| Experimental | Hours Until Discharge Readiness | 55 hours |
Secondary
Opioid Consumption
Amount of opioid consumed as measured with intravenous morphine equivalents in milligrams
Time frame: Postoperative Days 0-3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Opioid Consumption | Postoperative Day 1 (Day) | 11.0 milligrams | Standard Deviation 6.9 |
| Control | Opioid Consumption | Recovery Room | 8.6 milligrams | Standard Deviation 7.6 |
| Control | Opioid Consumption | Postoperative Day 1 (evening) | 8.6 milligrams | Standard Deviation 5.5 |
| Control | Opioid Consumption | Postoperative Day 0 (evening) | 7.2 milligrams | Standard Deviation 6.5 |
| Control | Opioid Consumption | Postoperative Day 2 (night) | 4.1 milligrams | Standard Deviation 4.6 |
| Control | Opioid Consumption | Postoperative Day 2 (evening) | 6.5 milligrams | Standard Deviation 5.8 |
| Control | Opioid Consumption | Postoperative Day 2 (day) | 9.6 milligrams | Standard Deviation 6.5 |
| Control | Opioid Consumption | Postoperative Day 1 (night) | 5.1 milligrams | Standard Deviation 6.7 |
| Control | Opioid Consumption | Postoperative Day 3 (night | 4.9 milligrams | Standard Deviation 6.4 |
| Control | Opioid Consumption | Postoperative Day 0 (day) | 0.9 milligrams | Standard Deviation 2.3 |
| Experimental | Opioid Consumption | Postoperative Day 3 (night | 5.1 milligrams | Standard Deviation 5.8 |
| Experimental | Opioid Consumption | Recovery Room | 8.0 milligrams | Standard Deviation 8.5 |
| Experimental | Opioid Consumption | Postoperative Day 0 (day) | 1.5 milligrams | Standard Deviation 4.6 |
| Experimental | Opioid Consumption | Postoperative Day 0 (evening) | 8.5 milligrams | Standard Deviation 6.2 |
| Experimental | Opioid Consumption | Postoperative Day 1 (night) | 5.6 milligrams | Standard Deviation 6.5 |
| Experimental | Opioid Consumption | Postoperative Day 1 (Day) | 12.6 milligrams | Standard Deviation 10 |
| Experimental | Opioid Consumption | Postoperative Day 1 (evening) | 10.9 milligrams | Standard Deviation 6.3 |
| Experimental | Opioid Consumption | Postoperative Day 2 (night) | 5.6 milligrams | Standard Deviation 6.2 |
| Experimental | Opioid Consumption | Postoperative Day 2 (evening) | 7.2 milligrams | Standard Deviation 6.5 |
| Experimental | Opioid Consumption | Postoperative Day 2 (day) | 10.2 milligrams | Standard Deviation 6.8 |
Secondary
Pain Level
The amount of pain evaluated using the 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain
Time frame: Postoperative Days 1-3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Pain Level | Postoperative Day 1 (08:00-16:00) | 4.4 score on a scale | Standard Deviation 2 |
| Control | Pain Level | Postoperative Day 2 (08:00-16:00) | 3.7 score on a scale | Standard Deviation 1.9 |
| Control | Pain Level | Postoperative Day 3 (00:00-8:00) | 2.5 score on a scale | Standard Deviation 2.1 |
| Experimental | Pain Level | Postoperative Day 1 (08:00-16:00) | 3.7 score on a scale | Standard Deviation 2.3 |
| Experimental | Pain Level | Postoperative Day 2 (08:00-16:00) | 3.4 score on a scale | Standard Deviation 2.1 |
| Experimental | Pain Level | Postoperative Day 3 (00:00-8:00) | 2.8 score on a scale | Standard Deviation 2.1 |
Secondary
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
Time frame: First 7 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time to Adequate Analgesia | 61.6 Hours | Standard Deviation 20.2 |
| Experimental | Time to Adequate Analgesia | 61.0 Hours | Standard Deviation 19.3 |
Secondary
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)
Time frame: 7 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time Until Ambulation at Least 30 Meters | 40.9 Hours | Standard Deviation 13 |
| Experimental | Time Until Ambulation at Least 30 Meters | 56.6 Hours | Standard Deviation 16.7 |
Secondary
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)
Time frame: First 7 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time Until Independence From Intravenous Analgesics of at Least 12 Hours | 46.1 Hours | Standard Deviation 20.1 |
| Experimental | Time Until Independence From Intravenous Analgesics of at Least 12 Hours | 47.5 Hours | Standard Deviation 22.7 |
Secondary
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.
Time frame: Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time Until Timed Up and Go Test Achieved | 33.4 Hours | Standard Deviation 7 |
| Experimental | Time Until Timed Up and Go Test Achieved | 46.8 Hours | Standard Deviation 14.5 |