The Use of Lumbar Erector Spinae Plane Block for Hip Arthroplasty at the L4 Interspace- a Randomized Controlled Study Comparing the 24-hour Opioid Requirements.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Opioid Consumption in PACU and 24 hours post surgery
研究概览
简要总结
Over 300,000 hip arthroplasties are performed each year in the United States.1 This number has been steadily increasing over the last two decades, likely due to increased life expectancy and, more significantly, the obesity epidemic. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.2 Moreover; optimal pain management can reduce the duration of hospitalization and the risk of adverse events, such as deep vein thrombus. The use of regional anesthesia reduces the postoperative opioid requirement, thereby decreasing the degree to which patients suffer the side effects of opioids, namely sedation and constipation, and less frequently nausea, vomiting, respiratory depression, pruritus, and retention. In the past, femoral nerve block, fascia iliaca compartment block, lumbar plexus block and the quadratus lumborum block have been shown efficacious for pain relief for hip arthroplasty. However there are several risk factors such as quadricep weakness and difficulty of the block that causes a limitation in the used of this blocks. Recently, the erector spinae plane block has been introduced as an alternative to the blocks above. This block was first described in the literature in 2016 when it was used to treat chronic neuropathic thoracic pain. Since then, there have been studies demonstrating its efficacy with a thoracic approach for analgesia in breast surgery and rib fractures.9 Only two case reports to date have demonstrated a lumbar approach to achieve analgesia for hip arthroplasty.10,11 The purpose of the study is to determine whether or not a lumbar erector spinae plane block is effective at improving postoperative pain in patients receiving hip arthroplasty.
详细描述
Hypothesis:
The erector spinae plane block will decrease opioid requirements in patients undergoing hip arthroplasty as compared to patients that do not receive the block.
Primary Objective:
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
Secondary Endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary hip arthroplasty
- •American Society of Anesthesiologists (ASA) Category 1, 2, and 3
- •Patients age ≥18 years
排除标准
- •Patient refusal
- •Inability to understand and sign consent
- •Infection at the injection site
- •Known allergy or hypersensitivity to ropivacaine or other amide local anesthetics
- •Contraindication or patient refusal to get spinal anesthesia
- •Thrombocytopenia (platelets < 100,000)
- •Coagulopathy (INR > 1.4)
- •Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time before the surgery
- •ASA Category 4 and 5
研究组 & 干预措施
Ultrasound-guided Erector Spinae Block
Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.
干预措施: Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375% (Procedure)
Ultrasound-guided Erector Spinae Block
Patients will then be randomized into one of the two groups above. One group will receive a lumbar erector spinae block at L4 with 30ml of 0.375% ropivacaine with 50 mcg of dexmedetomidine before the procedure using ultrasound guidance. The second group will receive no peripheral nerve block to serve as the control. All patients receiving nerve blocks will have a printed image of the block thus to confirm proper spread of local anesthetic both cranially and caudally.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Opioid Consumption in PACU and 24 hours post surgery
时间窗: 24 hours
To compare the opioid consumption in the post-anesthesia care unit (PACU) and at 24 hours postoperative (in morphine equivalents) in patients receiving regional anesthesia with spinal vs. spinal alone.
次要结局
- Pain scores at 2 hours post PACU discharge(2 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain)
- To evaluate the sensory distribution of the block (T10-L5).(2 hours post-surgery)
- To evaluate whether or not patients that receive the block have evidence of quadricep muscle weakness(30 hours post-surgery)
- Pain scores at 24 hours post PACU discharge(24 hours. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain)
- Pain scores at 48 hours postoperative(48 hours post-surgery. Pain scores from 1 to 10. 10 being the worse pain and 1 being the least pain)