Erector Spinae Plane Block (ESPB): A New Technique for Perioperative Pain Control in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain
研究概览
简要总结
Using a randomized double-blinded study design, the study goal is to evaluate the superiority of Erector Spinae Plane block (ESPB) in the peri-operative pain management of patients undergoing surgery through a flank or anterior subcostal incision as compared to the standard of care of using IV and oral opiates.
详细描述
40 subjects will be randomized in to 2 groups, with 20 in each group.
- Group 1. Erector spinae plane block (ESPB) (containing Ropivacaine)
- Group 2. Sham Erector spinae plane block. (SESPB) (with normal saline)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults age 18-85
- •American Society of Anesthesiologists (ASA) Physical Status classification I to III
- •Planned to be hospitalized for at least 24 hours post-op
- •Cognitive capacity to use the visual analogic scale (VAS) and complete the patient satisfaction survey
排除标准
- •Patient refusal
- •Patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone)
- •Scoliosis
- •Patients with chronic pain syndromes or who are on chronic pain medications/other neurologic medication of more than 3 months or whom have neuromodulators/stimulators
- •Concurrent surgeries requiring additional incisions on the body
研究组 & 干预措施
Ropivicaine
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
干预措施: Ropivacaine (Drug)
Normal Saline
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
干预措施: Normal saline (Drug)
结局指标
主要结局
Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain
时间窗: Aggregate pain scores for average length of hospital stay which is 3 days
Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain
次要结局
未报告次要终点
研究者
Alireza Aminsharifi
Assistant Professor of Surgery
Milton S. Hershey Medical Center