The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
研究概览
简要总结
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for total knee arthroplasty
- •American Society Anesthesiologists (ASA) physical status I- III.
- •Mentally competent and able to give consent for enrollment in the study.
排除标准
- •Patient refusal,
- •allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
- •Revision surgery will be excluded.
- •Impaired kidney functions
- •patient with coagulopathy will be also excluded.
- •Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
- •BMI of 45 or more
研究组 & 干预措施
ACB + iPACK
Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK).
干预措施: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) (Drug)
结局指标
主要结局
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
时间窗: Six hours after surgery
Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator
次要结局
- Pain Score Measurement Reported by Patients(24 hours after surgery)
- Quality of Recovery (QoR) Score(one week, measurements are obtained at 24 hours, 48 hours, and one week)