The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Numeric Pain Score
研究概览
简要总结
The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
详细描述
Research Summary
Purpose of Study This prospective, randomized, blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty (TKA) with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 0.5% in conjunction with a continuous femoral nerve catheter.
We believe the results of this study will show an improvement in pain control and physical therapy outcomes compared to traditional methods of analgesia in post-op total knee arthroplasty. To the best of our knowledge, there are no studies in the literature using this combination of femoral nerve analgesia and posterior capsular injection.
Certainly regional anesthesia methods such as femoral nerve blocks used alone or in conjunction with sciatic nerve blocks have improved patient pain outcome measures in total knee arthroplasty. Several studies have shown a beneficial effect of intra-articular analgesia after capsular closure. We believe our study design will combine the beneficial effects of the aforementioned methods, and ultimately improve patient pain, therapy effort, and safety through less narcotic use.
Our goal is to share these results in a peer-reviewed journal, and at national orthopaedic or anesthesia meetings. The data collected will ideally improve care and safety in the post-operative total knee arthroplasty patient.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is scheduled to undergo elective total knee replacement at Duke University Hospital.
- •The subject has signed the written consent form.
排除标准
- •Known allergy to ropivacaine or hydromorphone.
- •Known history of narcotic abuse or alcohol abuse.
- •Known history of chronic pain.
- •Known diagnosis of peripheral neuropathy or complex regional pain syndrome.
- •Significant impediment to physical therapy participation.
- •The surgery is a revision case.
- •Patient is undergoing bilateral Total Knee Replacement.
研究组 & 干预措施
Block Negative
Subjects receive intra-op saline injection per protocol
干预措施: Placebo saline injection (Other)
Block Positive
Subjects receive intra-op Ropivicaine 0.5% injection per protocol
干预措施: Ropivicaine 0.5% (Drug)
结局指标
主要结局
Numeric Pain Score
时间窗: Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection
Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).
次要结局
- Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion(24 hours post-op)
- Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise(4 hours, 8 hours, 12 hours and 24 hours post-op)
- Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption(4 hours to 24 hours post-op)
- Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance(24 hours post-op)