Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS)- Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Opioid consumption during 24-48 hour period
研究概览
简要总结
A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).
详细描述
Patients will be randomized to one of two groups: one group will receive a PAI, IPACK and single-shot adductor canal block; one group will receive PAI, IPACK and continuous adductor canal block catheter.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (secondary outcomes include questionnaires validated in English only)
- •Lives within one hour of the hospital
- •Has a smart phone
排除标准
- •Hepatic or renal insufficiency
- •Younger than 18 years old or older than 65 years ol
- •Patients undergoing general anesthesia
- •Allergy or intolerance to one of the study medications
- •American Society of Anesthesiologists (ASA) status III or IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing scale (PCS >30)
- •Patients with severe valgus deformity or flexion contracture
- •Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter
- •Patients who have no home caregivers in the event that a catheter is to be sent home with the patient
- •Patients with planned stay at rehab facility (to avoid medical device being tampered with at the rehab facility)
- •Non-English speakers (secondary outcomes include questionnaires validated in English only)
研究组 & 干预措施
Continuous Adductor Canal Catheter (ACC)
Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter
干预措施: Continuous Adductor Canal Catheter (ACC) (Device)
Adductor Canal block with sham catheter
Patients will receive a combined spinal epidural, PAI, IPACK, and an adductor canal block. The patient will also receive a sham catheter.
干预措施: Adductor Canal block with sham catheter (Device)
结局指标
主要结局
Opioid consumption during 24-48 hour period
时间窗: Post-operative day 1-2 (24-48 hours post spinal induction)
Patients will be asked to report their opioid consumption during the 24-48 hour time period after spinal induction. This data will be converted to morphine milligram equivalents (mme).
次要结局
- Opioid consumption during post-anesthesia care unit (PACU) stay(Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours))