A Randomized Controlled Double Blinded Multicentre Study Comparing Discharge Readiness of Combined Adductor Canal and IPACK Blocks to LIA for Knee Arthroplasty Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Time to achieve a collective four-point criterion for readiness to discharge from hospital after knee arthroplasty surgery.
研究概览
简要总结
Osteoarthritis of the knee is a common disease of the elderly and knee arthroplasty is indicated in severe cases to improve long term pain and function. Along with perioperative quality analgesia, functional recovery is paramount in the postoperative period.Loco-regional techniques provide effective analgesia and can mitigate several side effects of systemic opioids administration. Also, adequate motor sparing analgesia( to prevent weakness of the thigh muscle) following total knee arthroplasty (TKA) is therefore paramount to ensure effective rehabilitation, early recovery, readiness to discharge or timely hospital discharge.
There are several motor sparing regional technique described in literature. Adductor canal block (ACB), use of intrathecal ( IT) morphine and local infiltration by the surgeons (LIA) are such examples. Previous studies have shown the combination of ACB and IT morphine to be superior than LIA in providing analgesia.
Posterior knee infiltration (IPACK), involves blocking the branches of the tibial nerve which provides sensory innervation for the posterior aspect of the knee. In combination with ACB, a motor sparing analgesic intervention is possible for knee arthroplasty.
Rationale for doing the study is to evaluate
- The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery.
- Enhanced recovery from superior motor sparing analgesia.
- early hospital discharge We hypothesize that, following total knee arthroplasty surgery, the combination of continuous adductor canal catheter and I-PACK blocks will achieve a decrease in the time to readiness to hospital discharge as measured by the following four criteria: (1) adequate analgesia; (2) independence from intravenous opioids; (3) ability to independently stand, walk 3 m (metres), return, and sit down; and (4) independently ambulate 30 m without limitation of time. We postulate this will occur by providing superior motor-sparing analgesia compared to LIA for knee arthroplasty surgery.
详细描述
Introduction Osteoarthritis of the knee is a common disease of the elderly and knee arthroplasty (TKA) is indicated in severe cases to improve long term pain and function. Inadequate perioperative pain control is a strong predictor of persistent pain beyond 3 months.
Analgesic modalities for TKA Several analgesia regimes exist for TKA. Multimodal regimens including both loco-regional techniques or systemic analgesics. Loco-regional techniques provide effective analgesia and can mitigate the side effects of systemic opioids including nausea and vomiting, pruritus, respiratory depression and urinary retention.
Muscle weakness following regional anesthesia technique may induce fall, hinder early rehabilitation and prolong hospitalization. Motor sparing analgesic (do not cause weakness of muscles) are in vogue due to enhance early rehabilitation and analgesia. Local Infiltration Analgesia (LIA), Adductor Canal Block (ACB) and posterior infiltration of the knee (IPACK) are examples of motor sparing interventions utilized for TKA surgery.
LIA involves the injection of high volumes of dilute local anesthetic solution directly into the articular and peri-articular tissues during the surgical procedure.
ACB consists on the administration of local anesthetic in the adductor canal, an aponeurotic compartment in the mid-thigh containing the femoral vessels and several distal branches of the lumbar plexus that contribute to the innervation of the anterior aspect of the knee.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status I-III
- •18 -70 years of age
- •BMI 18 - 40
- •Scheduled for elective unilateral primary total knee arthroplasty under spinal anesthesia.
- •Able to ambulate independently with a standard wheeled walker as maximum mobility aid.
排除标准
- •Revision knee arthroplasty
- •Bilateral knee arthroplasty
- •Inability to provide informed consent
- •Patient scheduled for a second knee arthroplasty operation at a later date.
- •Neuropathic pain or sensory disorders of the surgical limb already diagnosis by a physician.
- •Contraindication to regional anesthesia.
- •Chronic opioid use defined as > 60 mg of daily oral morphine equivalents.
- •Patients who did not receive spinal anesthesia with intrathecal morphine or needed general anesthetics due to failed spinal anesthesia
结局指标
主要结局
Time to achieve a collective four-point criterion for readiness to discharge from hospital after knee arthroplasty surgery.
时间窗: 3 days
1- adequate analgesia - pain score less than 4 on numerical rating scale of 11. (0 signifies no pain and 10 signifies maximum possible pain). Assessment will be performed in postoperative care unit (PACU) and every 12 hours till hospital discharge. 2 - independence from intravenous opioids. Assessment will be performed in postoperative care unit (PACU) and every 12 hours till hospital discharge. 3 - ability to independently stand, walk 3 metres (m), return and sit down (TUG test). Assessment will be performed every 12 hours till hospital discharge. 4 - independently ambulate 30m with or without mechanical support (crutch) without any time limit. Assessment will be performed every 12 hours till hospital discharge.
次要结局
- Post-Operative pain scores(3 days)
- Total length of hospital stay(3 days)
- Total opioid consumptions in I.V. morphine equivalents(3 days)
- Nausea and vomiting(3 days)
- Pruritus(3 days)
- Functional outcomes(3 days and at 3rd month)
- urinary retention(3 days)
- Respiratory Distress(3 days)
研究者
Abhijit Biswas
Assistant Professor
Western University, Canada