Comparison of Pain Levels and Opioid Usage in ACB + Periarticular Block vs. ACB + IPACK Block vs. ACB + IPACK + Periarticular Block in Patients Undergoing Primary TKA
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Distance that patient is able to walk
研究概览
简要总结
The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
- •Patient age is 22-89 at time of TKA surgery.
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
- •Patient is able to read and speak English.
排除标准
- •Patient is under the age of 22 or over the age of
- •Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
- •Patient is scheduled to undergo a bilateral TKA surgery.
- •Patient is unable to read and speak English.
结局指标
主要结局
Distance that patient is able to walk
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk, as measured in feet
Visual Analog Scale
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.
WOMAC score
时间窗: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively
WOMAC score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.
Ability to rise from a chair independently
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently (Yes/No)
total length of hospital stay
时间窗: outcome measure will be taken at 2 weeks postoperatively
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Knee Society Score
时间窗: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) and 6 weeks (± 2 weeks) postoperatively.]
Knee Society Score as recorded preoperatively and 6 weeks (± 2 weeks) postoperatively. The score is on a scale from 0-100. A higher value represents a better outcome
Amount of narcotic medication utilized
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Use of an ambulatory assistive device
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device (Yes/No)
Active range-of-motion (ROM)
时间窗: outcome measure will be taken 24 hours postoperatively, 48 hours postoperatively, 72 hours postoperatively, 2 weeks (± 4 days) postoperatively, and 6 weeks (± 2 weeks) postoperatively
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Incidence of postop complications
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Incidence of any postoperative complication that involves hospital readmission and/or a re-operation of the surgical knee.
次要结局
未报告次要终点
研究者
Arthur Malkani
Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery
University of Louisville