Compared Erector Spinae Plane Block (ESP) Block for Pain Control With Traditional Pain Management Techniques in Patient Undergoing Thoracic and Abdominal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
The patients will be randomly assigned to standard therapy or standard therapy+ESP nerve block. After surgery pain level and narcotic consumption will be measured, and vital signs and side effects will bo monitored for up to 72 hours. 6 months after surgery a phone interview will be conducted to asses chronic pain
详细描述
patients will be divided randomly into two groups before the beginning of operation: Group 1: patients will be treated to standard pain control treatment ; Group 2: patients will receive Erector spinea block (30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone injection using ultrasound approach) additionally to standard pain control treatment The ESB (erector spinae plane block) will be performed at the beginning of the procedure while the patient under general anesthesia, in assistance of ultrasound for visualization, anesthetic injection 30-40 mL Ropivacaine 0.375% plus 2 mg Dexamethasone administered on each side between thoracic transversus process and longitudinal spinea muscle. in the the postoperative care room, the vital sings and pain level will be continuously monitored.
During the postoperative period stay the pain level of each patient will be assessed by of Visual Analog Score of pain (VAS: 0-10) interviewing the patient every 30 minutes from the patient's admission from operation room and thereafter every 1 - 4 -8 -12 -24 -48 - 72 hours, at discharge, 7- 14-21 days.
For a more accurate assessment of pain, a pre-operative baseline level of pain eill be recorded.
Any postoperative pain will be routinely managed by 5-10 mg of intravenous morphine to achieve a VAS scale of none or mild pain (1-5). investigators will also continue to record events of postoperative nausea and vomiting (PONV) within 24 hours after procedure. The PONV will be assessed by the PONV Impact Scale score, based on numerical responses to questions. A PONV Impact Scale score of ≥5 defines clinically relevant PONV.
Recording of urinary retention, constipation, opioid requirements and itching will also be preformed.
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
- Single (Participant)
盲法说明
The block will be preformed under anesthesia. The patients will not know what intervention group they are allocated
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing thoracic surgery, older ≥18 years
- •Patients who meet criteria of ASA (american society of anesthesiologists) physical status I-II-III class.
排除标准
- •Patients who will be unconscious or mentally incompetent
- •Patients refusal to participate in the study
- •Patient with coagulopathy
- •Hemodynamically unstable (systolic blood pressure < 90, heart rate (HR) > 100)
- •Allergy to local anesthetic drugs or opioids
- •Pregnant patient
- •History of opioid abuse
结局指标
主要结局
VAS score
时间窗: day 21 postoperative
the patients reported pain level using the VAS score
opioid consumption
时间窗: postoperative - 72 hours
total morphine administered (in mg)
次要结局
- blood pressure(postoperative - 24 hour)
- chronic pain - sleep(postoperative - 6 months)
- heart rate(postoperative - 24 hour)
- PONV(postoperative - 24 hour)
- chronic pain - VAS(postoperative - 6 months)
- chronic pain - opioid use(postoperative - 6 months)
研究者
Michael Dubilet MD
head of acute pain care unit
Soroka University Medical Center