Interspace Between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) Block for Postoperative Rehabilitation in Total Knee Arthroplasty: a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Opioid consumption 48 hours postoperatively
研究概览
简要总结
This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the rehabilitation process of the Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block in total knee arthroplasty.
详细描述
The Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block, has been recently described and shows promise in providing analgesia to the knee joint. The effect of this block on postoperative rehabilitation is uncertain. This study aims to compare a preoperative iPACK block to a placebo block prior to total knee arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.
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, Investigator)
盲法说明
Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately before the nerve block. One group will receive an iPACK block, and the other will receive a placebo block. The provider performing the league will not be blinded. However, all other care team members, the patient, and the investigator collecting data will be blinded to randomization.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients > 18 years old undergoing unilateral total knee arthroplasty
排除标准
- •refusal to participate
- •Chronic opioid use
- •localized infection
研究组 & 干预措施
preop iPACK block
Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.5% ropivacaine is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.
干预措施: Ropivacaine 0.5% Injectable Solution 20mL (Drug)
preop placebo block
Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.9% normal saline is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.
干预措施: 0,9% normal saline 20mL (Drug)
结局指标
主要结局
Opioid consumption 48 hours postoperatively
时间窗: 24-48 hours postoperatively
intravenous morphine equivalents (mg)
Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]
时间窗: 5 th postoperative day
NRS (numerical rating scale from 0- no pain to 10- the worst pain)
Time to first opioid administration
时间窗: 0-12 hours postoperatively
hours
Opioid consumption 24 hours postoperatively
时间窗: 24 hours postoperatively
intravenous morphine equivalents (mg)
Opioid consumption 72 hours postoperatively
时间窗: 48-72 hours postoperatively
intravenous morphine equivalents (mg)
Opioid consumption >72 hours postoperatively
时间窗: 72-96 hours postoperatively
intravenous morphine equivalents (mg)
次要结局
- Rehabilitation process Walking distance- by the balcony 5th day(5th postoperative day)
- Rehabilitation process Walking distance- impossible- bed bound 2nd day(2nd postoperative day)
- Rehabilitation process - getting out of bed- with help 1st day(1st postoperative day)
- Rehabilitation process - getting out of bed- with assistance 1st day(1st postoperative day)
- Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day(2nd day postoperative day)
- Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day(5th day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day(1st day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day(1st day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day(2nd day postoperative day)
- Rehabilitation process Verticalization by the balcony(5th postoperative day)
- Rehabilitation process Walking distance- unlimited with crutches 5th day(5th postoperative day)
- Rehabilitation process Verticalization with help(2nd postoperative day)
- Rehabilitation process Verticalization - impossible 1st day(1st postoperative day)
- Rehabilitation process Walking distance- unlimited with crutches 1st day(1st postoperative day)
- Rehabilitation process Walking distance- unlimited with crutches 2nd day(2nd postoperative day)
- Rehabilitation process Walking distance- by the balcony 1st day(1st postoperative day)
- Rehabilitation process Verticalization with help 5th day(5th postoperative day)
- Rehabilitation process Verticalization - impossible 2nd day(2nd postoperative day)
- Rehabilitation process Verticalization - impossible 5th day(5th postoperative day)
- Rehabilitation process Walking distance- by the balcony 2nd day(2nd postoperative day)
- Rehabilitation process Walking distance- impossible- bed bound 1st day(1st postoperative day)
- Rehabilitation process - getting out of bed- no problems 5th day(5th postoperative day)
- Rehabilitation process - getting out of bed- with help 5th day(5th postoperative day)
- Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day(1st day postoperative day)
- Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day(1st day postoperative day)
- Rehabilitation process - getting out of bed- no problems 1st day(1st postoperative day)
- Rehabilitation process - getting out of bed- no problems 2nd day(2nd postoperative day)
- Rehabilitation process - getting out of bed- with help 2nd day(2nd postoperative day)
- Rehabilitation process - getting out of bed- with assistance 2nd day(2nd postoperative day)
- Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day(5th day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day(2nd day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day(5th day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day(1st day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day(2nd day postoperative day)
- Rehabilitation process - getting out of bed- with assistance 5th day(5th postoperative day)
- Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day(2nd day postoperative day)
- Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day(5th day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 1st day(1st day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 1st day(1st day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 2nd day(2nd day postoperative day)
- Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 5th day(5th day postoperative day)