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Completed

NCT Number: NCT04639128

Adductor Canal Catheter Effectiveness and Safety Study

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

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Key information

Conditions

Total Knee Replacement Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

About this study

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:

  • Adductor canal catheter placement in the pre-operative area immediately prior to TKA surgery OR
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pain Numerical Rating Scale

    Time frame: Second postoperative day

    Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain

Secondary outcomes

  1. Opioid Consumption in the 15-day Postoperative Period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

An Open-Label Randomized Noninferiority Clinical Trial of the Adductor Canal Catheter for Pain Control Post-Total Knee Arthroplasty

Acronym: ACCESS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 20, 2020
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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