Comparison of Quadratus Lumborum Block With Medical Management for Pain Control After Lumbar Spine Fusion Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption.
详细描述
This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.
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
- Double (Participant, Outcomes Assessor)
盲法说明
For the blinding purposes, the patients will be told that there are two possible sites at which they will receive the block. The sites will be either in the operating room before you wake up from anesthesia or in the post-anesthesia care unit (PACU). The patients on the medical management group will be told that they have received their block before recovering from anesthesia, the PACU nurse will be told the same as well to make him or her blinded as a pain assessor.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients undergoing lumbar spinal fusion surgery.
- •Patients from 40-80 years.
排除标准
- •Recent drug abuse
- •History of illicit drug use
- •Chronic pain patients not related to the back lesions.
- •Opioid tolerant patients.
- •Patients with any lower extremity weaknesses or deficits.
- •Patients with American Society of Anesthesiologists (ASA) classification more than
- •Coagulopathy.
- •Infection near or in the area of the block.
- •Pregnant patients.
- •Uncooperative patients who refuse care which directly effects research participation or clinical care.
- •If the surgeon reports performing non-typical fusion.
- •The presence of intraoperative complications like nerve injury or abnormal results of neuromonitoring and extensive dissection.
- •Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.)
- •Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control)
研究组 & 干预措施
Group 1 Standard of Care
Group I will receive the standard of care multimodal pharmacological management.
干预措施: Multimodal Pharmacological Management (Drug)
Group 2 Standard of Care + Quadratus Lumborum Block II
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
干预措施: Ropivacaine injection Location 1 (Drug)
Group 2 Standard of Care + Quadratus Lumborum Block II
Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block.
干预措施: Multimodal Pharmacological Management (Drug)
Group 3 Standard of Care + Quadratus Lumborum Block III
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
干预措施: Ropivacaine injection Location 2 (Drug)
Group 3 Standard of Care + Quadratus Lumborum Block III
Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
干预措施: Multimodal Pharmacological Management (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: 48 hours
Dose of the opioids consumed
次要结局
- Pain Scale(48 hours)
- Discharge Opioid Use(2 weeks)
- Number of Participants Experiencing Side Effects(Up to 1 week)