Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain scores
研究概览
简要总结
In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.
详细描述
Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.
For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.
After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will 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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •lung resection with video-assisted thoracoscopy,
- •voluntarily agree to participate in the study,
- •over 18 years old,
- •ASA I-III
排除标准
- •Coagulation disorders or anticoagulant agent therapy,
- •Allergy or hypersensitivity to any drug to be will be used in the study,
- •Epilepsy,
- •High intracranial pressure,
- •Unwillingness to participate in the study
- •Inability to use the PCA device
研究组 & 干预措施
control group
Erector spinae plane block with 20 mL 0.5% bupivacaine
干预措施: Bupivacain (Drug)
ketamine group
Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine
干预措施: Ketamine Hydrochloride (Drug)
magnesium group
Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate
干预措施: Bupivacain (Drug)
magnesium group
Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate
干预措施: Magnesium sulfate (Drug)
ketamine group
Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine
干预措施: Bupivacain (Drug)
结局指标
主要结局
pain scores
时间窗: Change from baseline pain scores at 24 hours
postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)
morphine consumption
时间窗: Change from baseline morphine consumption at 24 hours
At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion.
次要结局
- side effects(postoperative 24 hours)
研究者
mediha turktan
associate professor
Cukurova University