Erector Spinae Plane Block in Patients Undergoing Lumbar Spine Fusion Surgery: Iohexol Spread, Extent of Block and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Verbal pain score as measured by the numerical rating scale (NRS)
研究概览
简要总结
As per usual care for spine surgery, participants will have their back cleaned with alcohol and a needle will be placed using ultrasound for the ESP block. Through the needle, a small catheter will be placed in the participants back and the needle removed. Approximately one hour prior to the start of surgery, a numbing medication (ropivacaine, similar to Novocaine) in combination with dexmedetomidine (a pain medicine that is used in nerve block and that is not a narcotic) and contrast dye (iohexol) will be injected through the catheter. Participants will then go through the QST procedure (test of buzzing sensation and temperature sensation through pads applied to their skin) to assess the numb areas and then head to the operating room. In the operating room, the catheter will be removed after the surgeon obtains baseline CT scan images of the spine. Once surgery is completed, investigators will record pain scores over the next four days in the hospital and the amount of pain medication needed for controlling pain related to the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: Adult patients 21-75 years of age
- •ASA status: I-III
- •Planned lumbar spine fusion involving no more than three levels
- •Ability to ambulate prior to surgery
排除标准
- •Previous lumbar spine surgery
- •Metastatic cancer with involvement of the lumbar spine
- •eGFR < 60 mL/min/1.73m2
- •Active liver disease (hepatitis or cirrhosis)
- •Confirmed allergy to ropivacaine, dexmedetomidine or iohexol
- •Cognitive impairment resulting in inability to rate pain scores
- •Patients receiving 30 mg or more of morphine equivalent daily dosing preoperatively
- •Pregnancy
研究组 & 干预措施
Spinal Surgery Participants
Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.
干预措施: Ropivacaine (Epidural analgesia) (Drug)
Spinal Surgery Participants
Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.
干预措施: Dexmedetomidine (Drug)
Spinal Surgery Participants
Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.
干预措施: Iohexol (Drug)
Spinal Surgery Participants
Participants scheduled for spinal surgery will have ESP block medications administered as per standard care along with contrast dye.
干预措施: QST Procedure (Procedure)
结局指标
主要结局
Verbal pain score as measured by the numerical rating scale (NRS)
时间窗: 12 hours after surgery
NRS rates pain intensity on a scale of 0 to 10, with 0 being no pain and 10 being worst possible pain.
次要结局
- Patient-reported outcome to assess the quality of recovery as measured by the QoR-15(Daily during hospital stay, up to 4 days)
- Time to oral food intake as measured by patient report(Daily during hospital stay, up to 4 days)
- Time to ambulation as measured by patient report(Daily during hospital stay, up to 4 days.)
- Length of hospital stay as measured by medical record review(Up to 5 days)
- Number of intraoperative events as measured by medical record review.(Up to 12 hours after surgery)
研究者
Salim M Hayek
Professor and Vice Chair for Clinical Research, Department of Anesthesiology
University Hospitals Cleveland Medical Center