The Ideal Analgesic Technique for Total Knee Arthroplasty: A Randomized Comparison Between Local Infiltration Analgesia Alone or Combined With Adductor Canal and iPACK Blocks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Quality of recovery (QoR-15)
研究概览
简要总结
LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. The combination of ACB-iPACK blocks has also been proposed as an effective analgesic modality for total knee arthroplasty. However, whether combining these two modalities yields any important incremental analgesic benefit remains unclear. The investigators hypothesized that the addition of ACB and iPACK blocks to LIA will yield clinically important analgesic benefits compared to LIA alone in patients having total knee arthroplasty.
详细描述
LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. Performed by surgeons, LIA provides effective postoperative pain relief and reduces opioid requirements. Similar analgesic benefits have also been attributed to adductor canal and iPACK blocks, which partially block sensory innervation to the knee and its posterior capsule. Performed by anesthesiologist preoperatively, these blocks have also been incorporated into the care standard in numerous centers. However, it is not clear whether adding the adductor canal and iPACK blocks yields any incremental analgesic benefits. The investigators aimed to evaluate the benefits of adding adductor canal and iPACK blocks to LIA in patients having total knee arthroplasty.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA classification I-III
- •BMI < 35 kg/m2
- •Having elective unilateral total knee arthroplasty
排除标准
- •Bilateral knee surgery.
- •Pre-existing neurological deficit or peripheral neuropathy in the lower the lower limbs
- •Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
- •Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
- •Contraindication to regional anesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
- •Patient refusal
- •Chronic pain disorder
- •Chronic opioid use (≥30 mg oxycodone / day)
- •Contraindication (or allergy) to a component of multi-modal analgesia protocol
- •Allergy to amide local anesthetics used in nerve blocks
- •Contraindications to spinal anesthesia
- •Significant psychiatric disorder that would preclude objective study assessment
- •Inability to provide informed consent
结局指标
主要结局
Quality of recovery (QoR-15)
时间窗: 24 hours postoperatively
Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.
Postoperative pain at rest
时间窗: over the first 24 hours
Area under the curve
次要结局
- Mean opioid analgesic consumption(24 hours postoperatively)
- Risk of opioid-related side effects(Up until one month following nerve block)
- Block-related complications(Up until one month following nerve block)
- Time to first analgesic request(Up to 48 hours following surgery)
- Pain Assessment (VAS)(at 0, 6, 12, 18 and 24 hours)
- Satisfaction with pain management(at 24 hours)