Comparison of the Effects of Remifentanil and Dexmedetomidine on Postoperative Acute Pain in Patients Who Received Erector Spina Plane Block in Spinal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.
Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain.
详细描述
investigators propose a randomized double-blind study comparing the use of intraoperative dexmedetomidine (Group D) for analgesic purposes with the use of intraoperative remifentanil (Group R) in patients undergoing ESP block for spinal surgery.
The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with.
Group 1: Dexmedetomidine infusion will be administered for intraoperative analgesia Group 2: Remifentanil infusion will be administered for intraoperative analgesia Routine anesthesia protocol in our clinic: patient is induced with fentanyl 1μg/kg IV and propofol 1.5 to 2 mg/kg IV, rocuronium 0.6 mg/kg IV. After putting the patients to sleep, ESP block is applied to the patients for postoperative pain management.
The peroperative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol was determined as 1 g and tramadol was determined as 1 mg/kg. Then it is paracetamol every eight hours and tramadol from PCA.
At the end of the operation, patients' pain levels will be determined and recorded with the Numeric Rating Scale (NRS) system at 4-hour intervals in the first 24 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Blindness patients and those who follow up after surgery will not know which group is in the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •18-75 years old
- •ASA Physical Status 1-3;
- •Patients planned for lumbar disc surgery
排除标准
- •Rejection during registration
- •Request for dismissal from employment
- •Inability to give informed consent
- •Emergency surgery
- •Bleeding diathesis
- •Chronic use of opioids
- •Psychiatric disorders
研究组 & 干预措施
group 1
Dexmedetomidine (dekstomid) infusion will be administered for intraoperative analgesia.
干预措施: esp Dexmedetomidine (dekstomid) (Drug)
group 2
remifentanyl (ultiva) infusion will be administered for intraoperative analgesia.
干预措施: esp remifentanyl (ultiva) (Drug)
结局指标
主要结局
opioid consumption
时间窗: 24 hours
Patients' opioid consumption on the PCA device will be recorded at 0, 3, 6, 12, 18, and 24 hours postoperatively.
次要结局
- The Numeric Rating Scale (NRS)(24 hours)
研究者
ferdi gülaştı
Principal Investigator
Aydin Adnan Menderes University