NCT04639128

Adductor Canal Catheter Effectiveness and Safety Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Total Knee Replacement Surgery

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-12-14
• Completion: 2023-01-13
• First posted: 2020-11-20
• Last updated: 2024-04-25
• Results posted: 2024-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study