The Influence of Postoperative Analgesia on Systemic Inflammatory Response and Postoperative Cognitive Disfunction in Elderly Patients After Surgical Repair of Femoral Fractures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Changes in Cognitive Function
研究概览
简要总结
The purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of femoral fractures.
详细描述
The research will be carried out at the Department of Surgery at Clinical Hospital Centre(CHC) Osijek after approval by the Ethics Committee of CHC Osijek and will be organized as a prospective randomized trial. Respecting the including and excluding criteria for participation in the study, the research will include 70 patients aged 65 years and over who are undergoing surgery for proximal femur fractures and will be operated with the same operating technique (osteosynthesis with nail). All participants will receive the same type of anesthesia and one of two forms of post-operative analgesia, so it will be divided into two groups (35 patients) depending on which form of post-operative analgesia receive. Randomization will be performed by drawing an envelope in which the specified one or other form of post-operative analgesia will be written. The study will be stopped in case of serious complications life-threatening (excessive sedation, respiratory insufficiency, hemodynamic instability and profound hypotension, heart rhythm disorders), which could possibly be related to the administration of drugs used for postoperative analgesia.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients age 65 and over
- •fracture of the proximal femur
- •preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
- •a written consent of the patient to participate in research
排除标准
- •patient non-compliance
- •ASA status IV and IV above
- •patients younger than 65 years
- •dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class C according to Child-Pugh's classification); severe kidney disease that require dialysis
- •result of MMSE test (Mini-Mental State Examination) under 17
- •the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.
研究组 & 干预措施
morphine
The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery
干预措施: morphine (Drug)
levobupivacaine
Upon completion of the operation for a period of 72 hours will be implemented continuous epidural local anesthetic through the Patient Controlled Analgesia (PCA) pump (Levobupivacaine 0.125%, basal flow of 6 ml / hour, a bolus dose of 2 ml, lockout interval of 20 minutes, hour limit of 3 doses).
干预措施: levobupivacaine (Drug)
结局指标
主要结局
Changes in Cognitive Function
时间窗: Before, 24,48,72,96 and 120 hours after the surgery
Assessment of cognitive function will be done using the Mini-mental state examination (MMSE) rating scales before and 24,48,72,96 and 120 hours after the surgery at the same time every morning. Mini-Mental State Examination Scale: minimum score is 0 and maximum score is 30; the severity of cognitive impairment: no cognitive impairment=25-30; mild cognitive impairment=19-24; moderate cognitive impairment=10-18; and severe cognitive impairment\<9. Higher scores mean a better and lower scores mean a worse outcome.
Interleukin-6 Concentration in Peripheral Blood.
时间窗: Before, 24 and 72 hours after the surgery
Measurement will be done before and 24 and 72 hours after the surgery.
次要结局
- Changes in Fibrinogen Concentrations in Peripheral Blood(Before, 24,72 and 120 hours after the surgery)
- Changes in Pain Intensity(During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily until discharge)
- Changes in C-reactive Protein (CRP) Levels(Before, 24,72 and 120 hours after the surgery)
- Postoperative Hospital Stay(14 days)