NCT03500744终止不适用
Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.
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, Care Provider)
盲法说明
Sham block will be performed
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
- •Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.
排除标准
- •Non-English speaking
- •Patient refusal or inability to consent
- •Cognitive or psychiatric history that would make it difficult to assess pain score
- •Pre-existing chronic pain condition
- •Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
- •Infection over site of block placement
- •Allergy or contraindication to any study medication
- •Coagulopathy or thrombocytopenia
- •Postoperative ICU admission
- •Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases
结局指标
主要结局
Pain score
时间窗: First 12 postoperative hour
Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours
Opioid consumption
时间窗: First 12 postoperative hour
Postoperative opioid consumption in oral morphine equivalents
次要结局
- Opioid consumption 12 - 24 hour(12th to 24th postoperative hour)
- Length of stay in hospital(until discharge from hospital, up to 7 days postoperatively)
- Number of participants with block related complication(Until discharge, up to 7 days postoperatively)
- Pain score 12 - 24 hour(12th to 24th postoperative hour)
- Length of stay in post-anesthetic recovery unit(until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively)
- Number of participants with opioid related complication(Until discharge, up to 7 days postoperatively)
研究者
Kamal Kumar
Associate Professor
Lawson Health Research Institute
研究点 (2)
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