Does Periarticular Injection (PAI) Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving Adductor Canal Block and Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (ACB&IPACK)? A Blinded, Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Pain Scores (NRS, 0-10) With Ambulation on POD1
研究概览
简要总结
The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is:
• Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?
Participants will be assigned to one of the following groups at random:
- ACB/PACK with PAI
- ACB/IPACK with saline injection
Participants will also be asked to complete pre- and post-operative questionnaires.
详细描述
Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents).
It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not, without obvious large differences in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in addition to ACB/IPACK, it is not desirable to perform unnecessary procedures.
In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned use of regional anesthesia
- •Ability to follow the major components of the study protocol
- •English speaking (Secondary outcomes include questionnaires validated in English only)
排除标准
- •Patients younger than 25 years old and older than 80
- •Non-English speaking
- •Patients intending to receive general anesthesia
- •Contraindication to nerve blocks or peri-articular injection
- •Patients with an ASA of IV or higher
- •Renal insufficiency (ESRD, HD, estimated creatinine clearance < 30 ml/min)
- •Patients with major prior ipsilateral open knee surgery
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months)
研究组 & 干预措施
No PAI + ACB & IPACK
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
干预措施: Saline Control Periarticular Injection (PAI) (Drug)
PAI + ACB & IPACK
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
干预措施: Periarticular Injection (PAI) (Drug)
结局指标
主要结局
Pain Scores (NRS, 0-10) With Ambulation on POD1
时间窗: 24 hours Post Operative Discharge
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.
次要结局
- Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)(post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.)
- NRS Pain With Movement(pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months)
- PAIN OUT Questionnaire at Preoperation(at preoperation)
- Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months(Pre operative, 3 months post operative discharge.)
- PAIN OUT Questionnaire at Post Operative Day (POD) 90(at post operative day (POD) 90)
- PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief(at preoperation)
- Numerical Rating Scale (NRS) Pain Score at Rest(from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months)
- Quality of Recovery (POD1)(24 hours post surgical discharge.)
- PAIN OUT Questionnaire at Post Operative Day (POD) 14(at post operative day (POD) 14)
- PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief(at post operative day (POD) 90)
- Side Effects: Opioid-Related Symptom Distress Score (POD1)(24 hours (POD 1) post surgical discharge.)
- Satisfaction With Pain Management (POD1)(24 hours post operative discharge.)
- Blinding Assessment; Bang Question (POD1)(24 hours post operative discharge)
- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(preoperatively, 6 weeks post operative discharge, 3 months post operative discharge)
- PAIN OUT Questionnaire at Post Operative Day (POD) 1(at post operative day (POD) 1)
- PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief(at post operative day (POD) 14)
- PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief(at post operative day (POD) 1)