Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Postoperative Opioid Usage
研究概览
简要总结
The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.
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
Participants will be masked to the treatment arm. The research team (outcomes assessors) involved in evaluation of subjects will be blinded to the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.
- •The individual is at least 18 years of age.
- •The individual is skeletally mature (over the age of 18).
- •The patient is scheduled for a one or two level lumbar spinal fusion.
排除标准
- •Patients unable to consent for themselves.
- •Pregnant women.
- •Non-English speaking subjects.
- •Prisoners.
- •Spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection.
- •Patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation.
- •Patients with a body mass index (BMI) of 40 or greater.
研究组 & 干预措施
Erector Spinae Plane Block
An erector spinae plane block (ESPB) will be administered prior to the surgical procedure, but after the patient receives general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected along the erector spinae fascial plane at the surgical levels. Fluoroscopy will be used for guidance during the injection.
干预措施: Erector Spinae Plane Block (Procedure)
Subcutaneous Anesthesia
A subcutaneous anesthesia injection will be administered after the surgery has been completed, but while the patient is under general anesthesia. The injection will consist of 10 mL of saline, 20 mL of liposomal bupivacaine, and 30 mL of bupivacaine. This will be injected around the surgical incision, subcutaneously.
干预措施: Subcutaneous Anesthesia (Procedure)
结局指标
主要结局
Postoperative Opioid Usage
时间窗: 2 weeks
This is a tracking sheet for the amount of opioid medications used in the first 2 weeks of postoperative recovery.
MOS 36 Item Short Form Health Status Survey (SF-36)
时间窗: 3 months
Questionnaire related to a patient's general health, bodily pain, physical function, and mental health. Scoring includes eight scaled scores, which are the weighted sums of the questions in their section. Scales are converted into a 0-100 scale. The lower the score the more disability. The higher the score the more functionality and therefore indicating better outcome.
Oswestry Disability Index
时间窗: 3 months
Questionnaire related to a patient's back pain and its impact on their day-to-day activities. There are 10 questions, each weighted from 0-5 points. The point total of each question is added together to give a final scaled score ranging from 0-50. Lower scores near 0 are indicative of better outcome and less disability, while higher scores near 50 indicate worse outcomes and more disability.
次要结局
未报告次要终点
研究者
Michael Stauff
Assistant Professor
University of Massachusetts, Worcester