Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Intravenous morphine consumption in the first 48 hours post-operatively
研究概览
简要总结
The aim of this study will be to compare the effects of morphine versus dexmedetomidine when used as adjuvants to local anesthetic (Ropivacaine) in Erector Spinae Plane Block under ultrasound guidance. A group without an adjuvant will also be compared to the groups.
详细描述
Erector Spinae Plane Block (ESPB) was first introduced in 2016 as a treatment technique for chronic thoracic neuropathic pain, and rapidly became popular in peri-operative medicine due to its relatively simple technique and low complication rate. It has been also used extensively in thoracic surgery. According to a systematic review, ESPB can be used effectively as part of multimodal analgesia in thoracic surgery since, when used, opioid consumption decreases.
The use of adjuvants has been studied to a limited extent in ESPB. Dexmedetomidine and dexamethasone have been tried as adjuvants in ESPB and it has been shown that dexmedetomidine is more effective in block prolongation and post-operative opioid consumption. According to our knowledge, morphine has not been used yet as an adjuvant for ESPB.
Therefore, the investigators will perform a randomized controlled trial in order to compare morphine and dexmedetomidine as adjuvants in ESPB in elective thoracotomies in terms of intraoperative and post-operative opioid consumption. Intraoperative opioid consumption will be guided by vital signs and Nociception-Level Index (NOL) and post-operative opioid consumption will be measured by the amount of morphine consumed by the patient during the first 48 hours post-operatively. Secondary outcomes will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective thoracotomy for any cause (ASA I-III)
排除标准
- •known allergy to local anesthetic
- •local inflammation
- •severe respiratory distress ( breathing dependence on accessory muscles)
- •severe spinal deformities
- •severe ipsilateral diaphragmatic paresis
- •morbid obesity (BMI>35 kg/m2)
- •blood coagulation disorder
- •known contraindication for administration of dexmedetomidine or morphine
- •severe cardiovascular disease
- •systematic use of opioids due to chronic pain
- •renal or hepatic failure
- •patients who refuse to participate.
研究组 & 干预措施
ropivacaine and morphine group
erector spinae plane block with a combination of ropivacaine and morphine
干预措施: erector spinae plane block with a combination of ropivacaine and morphine (Drug)
ropivacaine and dexmedetomidine group
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
干预措施: erector spinae plane block with a combination of ropivacaine and dexmedetomidine (Drug)
ropivacaine group
erector spinae plane block with ropivacaine only
干预措施: erector spinae plane block with ropivacaine only (Drug)
结局指标
主要结局
Intravenous morphine consumption in the first 48 hours post-operatively
时间窗: 48 hours post-operatively
Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 48 hours.
次要结局
- IV morphine consumption in the first 6 hours(6 hours post-operatively)
- IV morphine consumption in the first 12 hours(12 hours post-operatively)
- IV morphine consumption in the first 24 hours(24 hours post-operatively)
- Pain score 24 hours post-operatively(24 hours post-operatively)
- side effects post-operatively(48 hours post-operatively)
- Patient agitation- sedation status in the first 12 hours(12 hours post-operatively)
- Nausea and vomiting(24 hours post-operatively)
- Post-operative cognitive disorder (POCD)(48hours post-operatively)
- Post-operative Delirium (POD) Incidence(48 hours post-operatively)
- Intraoperative remifentanil consumption(Duration of operation)
- Intraoperative morphine consumption(Duration of operation)
- Pain score after surgery (PACU)(immediately post-operatively)
- Pain score 48 hours post-operatively(48 hours post-operatively)
- time to first request of analgesia(48 hours post-operatively)
- Patient agitation- sedation status post-operatively (PACU)(Immediately post-operatively)
- Patient agitation- sedation status in the first 24 hours(24 hours post-operatively)
- Pain score 6 hours post-operatively(6 hours post-operatively)
- Pain score 12 hours post-operatively(12 hours post-operatively)
- Chronic pain 3 months after operation(3 months post-operatively)
- satisfaction from post-operative analgesia(48 hours post-operatively)
- Patient agitation- sedation status in the first 6 hours(6 hours post-operatively)
- Patient agitation- sedation status in the first 48 hours(48 hours post-operatively)
- Chronic pain 6 months after operation(6 months post-operatively)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital