Use of Pre-operative Nerve Blocks in Older Patients With Hip Fracture: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Pain at rest
研究概览
简要总结
Hip fractures (broken hips) are common in older people, particularly older women with fragile bones, and usually occur with a simple fall from a standing height. In Canada, over 28,000 hip fractures occur every year, and approximately 900 occur in Edmonton. After a hip fracture, up to 50% of those who survive their hip fracture do not recover to the same level of activity that they had before breaking their hip. Managing pain with any broken bone is very important. For patients with hip fracture, their older age and fragile health makes pain management even more challenging. Many patients with a hip fracture have reduced ability to think clearly before the fracture. Some patients who have no difficulty with thinking before their hip fracture will become confused for a brief period after their hip fracture or can develop permanent difficulties with thinking. A hip fracture will usually require an operation, and choosing the right pain medication before and after the operation is important since many pain medications make confusion more likely. Permanent difficulty with thinking is a common reason for poor recovery after hip fracture. Our study will look at use of a nerve block to manage pain before patients have their operation. A nerve block provides local pain relief without requiring patients to take the medication by mouth (oral) or through an intravenous (IV) route. A nerve block before surgery may reduce the amount of oral and IV pain medication needed by the patient both before and after their operation but still provide good pain control with less confusion. This could lead to better recovery and allow more patients to return to living in the community rather than long-term care.
详细描述
Background and rationale
Hip fracture is a common injury in older people, with over 28,000 hip fractures occurring annually in Canada. Approximately 900 hip fractures occur in Edmonton each year. More than 90% of hip fractures result from simple low-energy falls. Many patients who survive do not recover to pre-fracture functional levels and may require permanent long-term care.
The immediate goal of treatment is to control pain while preparing the patient for surgery; greater than 95% of hip fracture patients are treated with surgery to restore mechanical stability and manage pain. Pain after hip fracture has been associated with delirium, depression, sleep disturbance, and decreased recovery. However, in the elderly population, narcotics are also associated with similar side effects such as delirium, cardiovascular and respiratory depression and nausea. This is complicated further in hip fracture patients, in whom pre-existing dementia is common - up to 50% of patients will present with altered cognition. Most studies that examine pain management interventions after hip fracture exclude those with pre-existing dementia. Further research to determine the feasibility of including subjects with cognitive impairment in pain management studies is needed.
Regional anaesthesia can reduce post-operative narcotic use. However, few randomized studies have examined the impact of preoperative regional anesthesia on postoperative outcomes. Effective pain management can affect long-term outcomes: poorly managed pain is associated with delayed ambulation, pulmonary complications, and delayed hospital discharge. Our previous work found limited evidence that nerve blocks may have benefits for hip fracture patients. Other prospective studies have reported the effectiveness of single nerve blocks in reducing narcotic use in Emergency rooms. Continuous preoperative femoral nerve blockade (CFNB) offers the potential benefit of reducing pain in these often frail patients well avoiding adverse outcomes such as delirium. Further work is needed to determine the effectiveness, timing, and safety of a preoperative CFNB on preoperative and postoperative outcomes in the frail hip fracture population, including those with cognitive impairment.
Study objectives
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
- Double (Participant, Outcomes Assessor)
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
- •Ambulatory pre-fracture
- •Sustained a low-energy hip fracture (i.e., fall from standing)
- •Mini Mental Status Examination (MMSE) score of 13 (moderate dementia) or greater
- •Consent to participate in study
排除标准
- •Failure to obtain consent
- •Admitted to hospital more than 30 hours from injury
- •Regular use of opiate medications
- •Confusion Assessment Method (CAM) test not performed within 6 hours of ward admission
- •Known allergy to local anesthetic
研究组 & 干预措施
Femoral nerve block
Patients will receive a pre-operative continuous femoral nerve block.
干预措施: Continuous femoral nerve block (Procedure)
Femoral nerve block
Patients will receive a pre-operative continuous femoral nerve block.
干预措施: 0.5% Ropivacaine/0.125% Bupivacaine local anesthetic mixture (Drug)
结局指标
主要结局
Pain at rest
时间窗: up to 5 days post-operative
Visual Analogue Scale and Checklist of Non-verbal Pain Indicators
Pain upon movement
时间窗: up to 5 days post-operative
Visual Analogue Scale and Checklist of Non-verbal Pain Indicators
次要结局
- Cognitive function(up to 5 days post-operative)
- Analgesia consumption(up to 5 days post-operative)