A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean cumulative opioid consumption up to 24 hours after surgery
研究概览
简要总结
Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.
详细描述
The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.
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, Outcomes Assessor)
盲法说明
Bandage with tape will be placed over the presumed site of anesthetic injection
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
- •Males or females 18-70 years of age
- •American Society of Anesthesiologists physical status class I,II, III
- •Signed informed consent
排除标准
- •Patients undergoing emergency surgery
- •Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
- •Comorbid obesity (BMI≥35kg/m2)
- •Anomalies of vertebral column
- •Use of anticoagulants and patients with hypocoagulable conditions
- •Physician preference for therapeutic anticoagulation
- •Infection of skin at site of needle puncture
- •Known allergies to study drugs
研究组 & 干预措施
Ropivacaine
Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance
干预措施: Ropivacaine (Drug)
Placebo
No injection. Bandage will be placed over the presumed site of injection
干预措施: Placebo (Other)
结局指标
主要结局
Mean cumulative opioid consumption up to 24 hours after surgery
时间窗: 24 hours post-operation
Cumulative opioid consumption will be recorded for 24 hours following surgery
次要结局
- Post-operative pain score(Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.)
- Time to ambulation(Between surgery and discharge from hospital, expected time is between 1 day to 1 week)
- Time to discharge(Expected time to discharge is up to 2 weeks)
- Usage of NSAIDs post surgery(Total dose used during the 24 hour period after surgery.)