Morphine Versus Ketamine as Adjuvants in Ultrasound-guided Paravertebral Thoracic Blocks in Elective Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- morphine consumption in the first 48 hours
研究概览
简要总结
The aim of this study will be to compare the effects of morphine versus ketamine when they are used as adjuvants to the local anesthetic in paravertebral nerve blocks performed with the aid of ultrasound. Furthermore, a group of local anesthetic without an adjuvant, will also be compared to the two groups
详细描述
Elective thoracotomies are usually performed for removal of pathological masses in the mediastinum, lung parenchyma and upper gastrointestinal system. They are considered to be painful operations, related to both acute and chronic pain (post- thoracotomy pain syndrome), the latter lasting for a minimum period of 2 months.
Post-operative thoracic pain is associated often with diaphragmatic dysfunction, which can also lead to atelectasis and pneumonia and post-operative pulmonary complications in general.
Several techniques have been tried in order to minimize such events. Thoracic epidural analgesia, intravenous analgesia, intercostal blocks, local infiltration of local anesthetics by the surgeon are some of them.
Paravertebral thoracic blocks have become increasingly popular in recent years since they are less likely to cause neurologic complications than thoracic epidural analgesia. Moreover, bleeding disorders, and use of anti-coagulant and anti- thrombotic medications, which are considered as contraindications to an epidural procedure, are not strict contraindications in the performance of paravertebral blocks, especially when they are performed under ultrasonographic guidance.
Ropivacaine and Levobupivacaine are the most popular local anesthetics that have been used. Moreover, several adjuvants have been added to them in order to enhance the effects of those blocks. Dexamethasone, Morphine, Dexmedetomidine, Clonidine, Ketamine, Magnesium Sulphate are some of them. Results are variable.
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
- •American Society of Anesthesiologists class I-III (ASA I-III)
排除标准
- •known allergy to local anesthetic
- •local inflammation
- •paravertebral tumor
- •severe respiratory distress ( breathing dependence on accessory muscles)
- •severe spinal deformities
- •severe ipsilateral diaphragmatic paresis
- •morbid obesity (BMI>35 kg/m2)
- •blood coagulation disorders
- •known contraindication for administration of ketamine or morphine
- •psychiatric disorders
- •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
local anesthetic and morphine group
paravertebral block with local anesthetic and morphine, followed by a continuous infusion of local anesthetic and morphine in the paravertebral space
干预措施: local anesthetic-morphine (Drug)
local anesthetic and ketamine group
paravertebral block with local anesthetic and ketamine, followed by a continuous infusion of local anesthetic and ketamine in the paravertebral space
干预措施: local anesthetic-ketamine (Drug)
local anesthetic group
paravertebral block with local anesthetic only, followed by a continuous infusion of local anesthetic only in the paravertebral space
干预措施: local anesthetic (Drug)
结局指标
主要结局
morphine consumption in the first 48 hours
时间窗: 48 hours postoperatively
patients will be followed for cumulative morphine consumption through patient-controlled analgesia device for 48 hours postoperatively
次要结局
- incidence of chronic pain 3 months after surgery(3 months after surgery)
- pain score 12 hours postoperatively(12 hours postoperatively)
- pain score 48 hours postoperatively(48 hours postoperatively)
- morphine consumption in the first 6 hours(6 hours postoperatively)
- morphine consumption in the first 12 hours(12 hours postoperatively)
- side effects postoperatively(96 hours postoperatively)
- satisfaction from postoperative analgesia(48 hours postoperatively)
- pain score on arrival to Post-Anesthesia Care Unit (PACU)(immediately postoperatively)
- morphine requirement during surgery(intraoperatively)
- time to first request for analgesia(during stay in Post-Anesthesia Care Unit, 24 hours postoperatively)
- hospitalization time(7 days postoperatively)
- morphine consumption in Post-Anesthesia Care Unit (PACU)(24 hours postoperatively)
- pain score 6 hours postoperatively(6 hours postoperatively)
- pain score 24 hours postoperatively(24 hours postoperatively)
- morphine consumption in the first 24 hours(24 hours postoperatively)
- incidence of chronic pain 6 months after surgery(6 months after surgery)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital