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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:
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-Device | No Intervention | No placement of an adductor canal catheter | |
| Device | Experimental | Placement of an adductor canal catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor Canal Catheter | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numerical Rating Scale | Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain | Second postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15 postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hinman, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente San Leandro | San Leandro | California | 94577 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26227922 | Background | Song MH, Kim BH, Ahn SJ, Yoo SH, Kang SW, Kim YJ, Kim DH. Peri-articular injections of local anaesthesia can replace patient-controlled analgesia after total knee arthroplasty: a randomised controlled study. Int Orthop. 2016 Feb;40(2):295-9. doi: 10.1007/s00264-015-2940-2. Epub 2015 Jul 31. | |
| 19916251 | Background |
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Consideration for sharing patient-level data will be made on case-by-case basis via contact with the study PI
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| ID | Title | Description |
|---|---|---|
| FG000 | No-Device | No placement of an adductor canal catheter |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No-Device | No placement of an adductor canal catheter |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Had surgery and able to provide postoperative day-2 pain score | Posted | Mean | Standard Error | score on a scale | Second postoperative day |
|
30 days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No-Device | No placement of an adductor canal catheter | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adrian Hinman | The Permanente Medical Group | 510-454-7292 | adrian.d.hinman@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Mar 26, 2024 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2020 | Nov 16, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Manickam 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. |
| 24401769 | Background | Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Numbers of participants do not equal those of the pain-score analyses due to missing data | Posted | Mean | Standard Error | 5mg oxycodone tablets | 15 postoperative days |
|
|
|
| 63 |
| 3 |
| 63 |
| 0 |
| 63 |
| EG001 | 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 | 0 | 63 | 1 | 63 | 0 | 63 |
| Small-bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |