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-blinded Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Opioid consumption at 24-48 hours
研究概览
简要总结
The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is:
1. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)?
Participants will be:
- Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter.
- Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place.
- Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.
详细描述
The purpose of this study is to see if adding a continuous ACB catheter will extend analgesia beyond the 24-48 hour period. This interventional clinical trial will assess opioid consumption in patients undergoing total knee arthroplasty 24 to 48 hours after anesthesia block. Rebound pain is a well-known phenomenon in which patients experience severe pain immediately after the nerve block is removed. It is also known that by extending the duration of analgesia, you can reduce or prevent rebound pain. Motor sparing compartment blocks have transformed patients' ability to participate in rehabilitation earlier than ever before, even ambulating on POD 0. Thus, by extending analgesia and encouraging early ambulation, adductor canal catheters are likely to not only reduce opioid consumption but also allow for earlier discharge. The two "hot" themes in recent total knee replacement analgesia pathways are not only providing an effective Enhanced recovery after surgery (ERAD) protocol, but also combating the opioid epidemic through regional anesthesia and non-opioid multimodal pathways. This study will assist in determining which modality is superior (single shot blocks with additive versus catheter) and will introduce a novel method of following patients at home via a transitional pain service (telemedicine). This research will further investigate chronic pain 6 months after surgery.
Patients in the intervention group will have a catheter that continuously infuses numbing medication into their operative leg for 50 hours (up to POD 3). It is hypothesized that the patient will have better pain control, mobility, and less rebound pain, which is common following POD 1. By infusing the catheter with a disposable single use ambIT system (Summit Medical Products), all patients enrolled in the intervention group (ACC) will have the same amount running continuously, allowing the patient to be discharged with the catheter in place before the 50-hour infusion is completed. Prior to discharge, patients will be instructed on how to remove the catheter and will be able to download the Smartphone app "Diagnotes" at the hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will be the patient's primary means of communication with the pain doctor at home.
Patients in the control group will have a sham (fake) catheter attached to their operative leg for 50 hours. Patients will also be instructed on how to remove the catheter prior to discharge and will be able to download the Smartphone app "Diagnotes" in the hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will be the patient's primary means of communication with the pain doctor at home.
Researchers will contact both groups for follow-ups for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomized to the intervention group (adductor canal catheter, ACC) or control group (sham adductor canal catheterm, ACB). The research staff and participants will be blinded as to which group the participant is in. The primary investigator and co-investigators will not be blinded. The research staff will provide PI and Co-I with an envelope that informs them which group the participant is randomized to so the proper research activities are carried out.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
- •Age 18 to 75 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •English speaking (secondary outcomes include questionnaires validated in English only)
- •Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
- •Lives within one hour of the hospital
- •Has a smartphone
排除标准
- •Hepatic or renal insufficiency
- •Younger than 18 years old and older than 65
- •Patients undergoing general anesthesia
- •Allergy or intolerance to one of the study medications
- •BMI > 40
- •ASA of III,IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •PCS > 30
- •Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
- •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 if a catheter is to be sent home with the patient
- •Patients with planned stay at rehab facility
研究组 & 干预措施
Adductor Canal Catheter (ACC) - Interventional
Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery.
Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.
干预措施: ambIT pump with catheter (Device)
Adductor Canal Block (ACB) - Control
Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery.
Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.
干预措施: ambIT pump with sham catheter (Device)
结局指标
主要结局
Opioid consumption at 24-48 hours
时间窗: from 24 hours to 48 hours
The cumulative opioid consumption 24-48 hours post block administration. Measured in morphine milligram equivalents per day. Although collected over a period of time, the total amount will be summed and the average will be reported.
次要结局
- Numerical Pain Rating Score(Day of surgery to post operative day (POD) 60)
- Hospital Length of Stay(up to 7 days after the day of surgery)
- Catheter related complications(up to post operative day 4)
- Opioid consumption at 72 hours, 96 hours, and 1 week(72 hours to 1 week)
- Physical Therapy Milestones(post operative day (POD) 1 up to POD 4)
- Pain catastrophizing scale (PCS)(before the surgery and up to post operative day 60)
- Blinding Assessment(up to post operative day 2)
- Opioid Related Symptom Distress Scale (ORSDS)(after the surgery end time, on post operative day (POD) 1, 4, and 60)
- Number of participants who experienced Buckling/Falls/Quadricep during physical therapy(On post operative day (POD) 1, 2, 3, 4)
- Incidents of participants experiencing a blood loss during surgical procedure(During surgery)
- Block resolution(Up to post operative day 3)
- Incidences of participants readmitted for pain control(3 month after surgery)
- SF-36 questionnaire(up to post operative day 60)
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)(at 3 months & 6 months)
- Current opioid misuse measure (COMM)(at 3 months & 6 months)
- Patient Satisfaction with Pain Control(post operative day (POD) 1, 2, 4 & 60)
- Orthopedic Outcome Flexion/Knee Society Score(6 weeks)
- Incidents of participants experiencing block complications(up to post operative day 4)
- Non Opioid Pain medications consumption(up to post operative day 60)
- Distance of ambulation(post operative day (POD) 0,1,2,3,4)
- Block complications(up to post operative day 4)
- Incidence of patient contact via text messaging/video calls(up to post operative day 4)
- Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)(before surgery and up to post operative day 60)
- Number of unused opioids(up to post operative day 7)
- Pain Disability Index (PDI)(3 months & 6 months)
- Intravenous patient control analgesia (IV PCA) usage(up to post operative day 7)
- Length of induction(During the surgical procedure)
- Length of tourniquet use(During the surgical procedure)