An Open-Label Randomized Noninferiority Clinical Trial of the Adductor Canal Catheter for Pain Control Post-Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Pain Numerical Rating Scale
研究概览
简要总结
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:
- 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
- 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
- To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits
- To conduct exploratory analyses to identify candidate predictors of differential response to the ACC
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center
- •Patient ambulates independently
排除标准
- •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
结局指标
主要结局
Pain Numerical Rating Scale
时间窗: Second postoperative day
Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain
次要结局
- Opioid Consumption in the 15-day Postoperative Period(15 postoperative days)