Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Respiratory complications
研究概览
简要总结
Hip fractures are a major cause of morbidity and mortality in the elderly with over 30,000 hip fractures occuring in Canada annually and over 1300 in Saskatchewan. The estimated cost associated with hip fractures is over $600 million nationally and 28 million dollars in Saskatchewan. Hip fractures cause a great deal of pain and immobility and are mainly treated with surgical fixation. In the perioperative period, hip fracture patients are treated mainly with opioids and other adjuncts such as NSAIDS and acetaminophen. Opioid consumption in the elderly population can predispose to delirium and respiratory complications such as atelectasis, respiratory depression, and pneumonia.
Fascia iliaca blocks have been shown to be an effective mode of analgesia for patients with hip fractures, but are underutilized for varying reasons including culture of practice, expertise with performing the block, and having a dedicated service to do so.
This study aims to compare the efficacy of fascia iliaca blocks to standard treatment (opioids) in the management of pain in hip fracture patients with a particular focus on outcomes such as the incidence of delirium, respiratory complications, and length of stay in hospital. Our idea is that if we can reduce the amount of opioids these patients receive then they will have improved pain control, fewer respiratory complications, earlier time to mobilizing, and shorter hospital stays. As far as we are aware this relation has not been well studied.
详细描述
This study is a prospective randomized controlled non-blinded pilot study.
Recruitment and Randomization: fifty adult patients with hip fractures for surgical fixation presenting to Royal University Hospital (RUH), Saskatoon, Saskatchewan, will be recruited. The exclusion criteria are:
- American Society of Anesthesiologists (ASA) score >3
- Other injuries that interfere with block positioning and assessment of pain
- Local anesthetic allergy
- Open fracture
- Moderate to severe pre-operative delirium (interfering with consent and assessment)
- Sepsis at site of injection
- Anticoagulation with warfarin or anti-Xa inhibitors
- Age less than 65 years
Patients will be randomized into one of two research arms: Continuous Fascia Iliaca block (cFIB) vs standard treatment (opioids). It is important to note here is that patients receiving cFIBs will have standard treatment orders available in the event of block failure, and opioid consumption will be monitored.
Methods:
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
- 否
入选标准
- •Adults age greater than or equal to 65 years old with acute hip fracture
排除标准
- •ASA greater than or equal to 4
- •Open fractures
- •Other concomitant injuries that may interfere with positioning or pain scores
- •Local anesthetic allergy
- •Delirium at the time of consent
- •Pre-existing cognitive impairment
- •Infection at the site of injection for cFIB
- •Previous surgery in femoral triangle
- •Warfarin or Anti-Xa inhibitor use
- •Long-term opioid use
- •Intraoperative complications
研究组 & 干预措施
Continuous fascia iliaca block
The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure.
The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter.
干预措施: Continuous fascia iliaca block (Procedure)
Continuous fascia iliaca block
The cFIB group will receive an ultrasound guided cFIB and standard treatment orders as backup in the event of block failure.
The cFIB group will receive an initial bolus of 40 cc of 0.25% Ropivacaine followed by an infusion of 8 cc/hr until the time of surgery. Immediately pre-operatively, the anesthesiologist performing the case will bolus the catheter 40 cc of 0.25% ropivacaine and discontinue the catheter.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Respiratory complications
时间窗: During hospital stay, up to 1 month
Use of supplemental oxygen, need for positive pressure ventilation, decreased oxygen saturations, radiographic evidence of atelectasis or pneumonia
次要结局
- Pain score(During hospital stay, up to 1 month)
- Opioid side effects(During hospital stay, up to 1 month)
- Delirium(During hospital stay, up to 1 month)
- Post op length of stay(During hospital stay, up to 1 month)
- 30 day mortality(Will be collected from hospital record, at up to 3 months after enrolment.)
研究者
Churao Yang
Anesthesiologist
University of Saskatchewan