Efficacy of Epidural Analgesia Initiated in the Preoperative Period in Lower Extremity Osteosarcoma
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Measurement of postoperative pain
研究概览
简要总结
In this study, the investigators aim to reduce complications in orthopedic malignancy surgeries and to increase the quality of life of patients who will be operated on.
详细描述
In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.
Patients in the first group will be provided with preoperative and peroperative analgesia with an epidural catheter. The second group patient will be get no block. Afterwards, both groups will be operated under similar general anesthesia conditions. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accepting the study protocol,
- •age older than 18 years and younger than 80 years,
- •undergoing lower extremity osteosarcoma surgery
- •the American Society of Anesthesiologist (ASA) physical status of I-II-III
排除标准
- •infection at the injection site
- •coagulation disorder
- •patients with central nervous system related disease
- •septic patients
研究组 & 干预措施
Study group; Epidural catheter and PCA
Epidural catheter will be placed in the preoperative period. After induction, 10 ml of 0.25% bupivacaine will be administered through the epidural catheter and bupivacaine PCA will be started.
干预措施: Epidural Analgesia (Procedure)
Control group; No block, IC PCA
Postoperative pain control will be achieved with intravenous morphine PCA.
结局指标
主要结局
Measurement of postoperative pain
时间窗: 48 hours
VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)
Opioid consumption
时间窗: 48 hours
miligram
次要结局
- Beck Depression Inventory (BDI)(Will be done 2 times 1- on pre-operative hospitalization 2- in the 1st month follow-up after surgery])
- Amount of peroperative bleeding(During surgery)
- Amount of postoperative bleeding(48 Hours)
- Patient satisfaction(Will be done 3 times 1- a day after surgery 2- in the 1st week follow up after surgery 3- in the 1st month follow-up after surgery)
- Postoperative complications(postoperative period up to 3 days)
- Intensive care unit stay(48 hours)
- Hospital stay(72 hours)
研究者
Nur Canbolat
Principle Invastigator, M.D.
Istanbul University