Adductor Canal Catheter Effectiveness and Safety Study (ACCESS)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    118
  • sponsor
    Kaiser Permanente
Updated on 7 October 2022

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

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, 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 3 months postoperatively

SAMPLE SIZE: 118 participants randomized using balanced allocation to the two study arms

Details
Condition Total Knee Replacement Surgery
Treatment Adductor Canal Catheter
Clinical Study IdentifierNCT04639128
SponsorKaiser Permanente
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Intending to undergo elective primary unilateral TKA at the KPNC 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
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