Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cognitive decline
研究概览
简要总结
Hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. Delirium is one of the common complications after hip surgery. Controversy exists regarding the possible impact of type of anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline.
The primary objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of post-operative analgesics with respect to the type of anesthesia.
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery.
详细描述
Prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The presence of CD will be determined at follow-up evaluation up to three months after surgery. Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (L3-L4 or L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4 and L4-L5 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)
- •40 kg in weight and higher
排除标准
- •Patients who are:
- •Uncooperative
- •Considered as moribund by the orthopedic surgeon at admission
- •Alzheimer
- •Severe cognitive impairment (MMSE<18)
- •Absolute contraindication for spinal anesthesia (assessed preoperatively)
- •Allergy to local anesthesia
结局指标
主要结局
Cognitive decline
时间窗: 3 months after operation
Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
次要结局
- Intra-operative hemodynamic changes(every 10 minutes intra-operative)
研究者
Zoher Naja
Anesthesiologist
Makassed General Hospital