Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative VAS Pain Scores
研究概览
简要总结
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.
Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.
Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.
详细描述
Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded by investigational drug service
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-88 years old
- •Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.
排除标准
- •Revision surgeries
- •Surgeries indicated for trauma, tumor, or infection
- •Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness
- •Known hypersensitivity to any of the RECK components
研究组 & 干预措施
Intervention (RECK)
The arm of patients who will be administered "RECK" local anesthesia cocktail:
Ropivacaine 0.125g Clonidine 80 mcg Epinephrine 0.5 mg Ketorolac 30 mg In sterile water 73 mL (total volume of compound is 100 mL)
Given through paraspinal muscle injection once intraoperatively.
干预措施: Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail (Drug)
Control Group (Placebo)
The arm of patients who will be administered a placebo injection:
100 mL Normal Saline
Given through paraspinal muscle injection once intraoperatively.
干预措施: Placebo (Other)
结局指标
主要结局
Postoperative VAS Pain Scores
时间窗: 2, 4, and 6 hours immediately postoperatively, then repeating once daily through hospital admission (an average of 4 days)
Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. VAS (Visual Analogue Scale) measures pain intensity. The VAS is a 10cm line with two end points representing 0 ("No pain") and 10 ("Pain as bad as it could be"). The patient is asked to rate their pain by placing a marker on the line. A lower score (thus closer to "no pain") is a better outcome.
次要结局
- Opioid Utilization(Postoperatively day 1, then repeating once daily through hospital admission (an average of 4 days))
- Hospital Length of Stay(Up to 2 weeks (an average of 4 days))
研究者
Steven Ludwig
Professor, Department of Orthopaedics
University of Maryland, Baltimore