Total Knee Replacement Surgery
Conditions
Keywords
analgesia, surgery, device
Brief summary
PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing elective primary unilateral total knee arthroplasty (TKA) SECONDARY OBJECTIVES: Among a sample of patients undergoing elective primary unilateral TKA who receive peri-articular anesthetic injections: 1. To compare the overall two-week levels of postoperative pain between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC 2. To compare the use of opioid medications (in mean total morphine milligram equivalents) between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC over the two-week postoperative period 3. To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits 4. To conduct exploratory analyses to identify candidate predictors of differential response to the ACC
Detailed description
DESIGN: Randomized, open-label, two-arm, parallel-comparison noninferiority trial POPULATION: Adults aged \>18 years intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California (KPNC), San Leandro Medical Center INTERVENTION: Participants will be randomized to one of two treatment arms: 1. Adductor canal catheter placement in the pre-operative area immediately prior to TKA surgery OR 2. No adductor canal catheter placement DURATION: The intervention phase will occur between randomization and three days postoperatively (or until the ACC is removed by the participant or the ACC falls out spontaneously among ACC-randomized participants); the primary outcome will be measured on postoperative day 2, secondary pain and medication outcomes will be collected for two weeks postoperatively and the electronic medical record (EMR) will be examined for evidence of adverse events at 30 days postoperatively SAMPLE SIZE: 118 participants randomized using balanced allocation to the two study arms
Interventions
DEVICEAdductor Canal Catheter
The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
Sponsors
Kaiser Permanente
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
* Intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center * Patient ambulates independently
Exclusion criteria
* Patient declines use of ACC * Surgeon decides that an ACC will not be placed for any reason * Known hypersensitivity to ropivacaine or any alternative anesthetic for ACC use * Hypersensitivity or inability to tolerate peri-articular injections of clonidine, epinephrine, bupivacaine and ketorolac * Any evidence of substance-use disorder in past year * Non-English speaking * Failure to complete all baseline study instruments prior to surgery * Requires secondary procedure at time of TKA (e.g., removal of hardware) * Not intending to use spinal anesthesia for TKA procedure * Actively enrolled in KPNC chronic-pain program * Having been prescribed long-acting opioid (e.g., Oxycontin, MS Contin) within 90 days prior to enrollment * Inability to tolerate any oral NSAID or acetaminophen or any short-acting opioid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Numerical Rating Scale | Second postoperative day | Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in the 15-day Postoperative Period | 15 postoperative days | Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No-Device No placement of an adductor canal catheter | 63 |
| Device Placement of an adductor canal catheter
Adductor Canal Catheter: The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days | 63 |
| Total | 126 |
Baseline characteristics
| Characteristic | No-Device | Total | Device |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 8.6 | 66.5 years STANDARD_DEVIATION 8.9 | 66.5 years STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) White | 44 Participants | 81 Participants | 37 Participants |
| Region of Enrollment United States | 63 participants | 126 participants | 63 participants |
| Sex: Female, Male Female | 36 Participants | 71 Participants | 35 Participants |
| Sex: Female, Male Male | 27 Participants | 55 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 0 / 63 | 0 / 63 |
| serious Total, serious adverse events | 3 / 63 | 1 / 63 |
Outcome results
Primary
Pain Numerical Rating Scale
Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain
Time frame: Second postoperative day
Population: Had surgery and able to provide postoperative day-2 pain score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No-Device | Pain Numerical Rating Scale | 6.38 score on a scale | Standard Error 0.3 |
| Device | Pain Numerical Rating Scale | 5.31 score on a scale | Standard Error 0.32 |
Secondary
Opioid Consumption in the 15-day Postoperative Period
Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary
Time frame: 15 postoperative days
Population: Numbers of participants do not equal those of the pain-score analyses due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No-Device | Opioid Consumption in the 15-day Postoperative Period | 41.9 5mg oxycodone tablets | Standard Error 4.2 |
| Device | Opioid Consumption in the 15-day Postoperative Period | 46.0 5mg oxycodone tablets | Standard Error 5.59 |