The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stress Response 1
研究概览
简要总结
BLOCKPAIN is a randomized controlled study, 80 participants. The participants will be hip fracture patients in Emergency Medicine Department in Clinical Hospital "Sveti Duh", Zagreb, Croatia. Upon patient arrival inclusion and exclusion criteria will be established. After signing the informed consent form participant will be randomized in one of two study groups. One study group is fascia iliaca compartment block (FICB), the other is placebo. All participants will be given paracetamol 1 gram IV as standard care. If needed, rescue analgesic will be tramadol 100 mg in 100 ml saline IV. The time frame is 24 hours after the FICB or placebo procedure.
详细描述
Hip fractures in older patients are a major public health problem. For acute pain management, nonopioid analgesics are often not sufficient enough, and opioids have many adverse events. For this reasons fascia iliaca compartment block could be the treatment of choice. The objective of this study is to evaluate the efficacy of the fascia iliaca compartment block for pain management in the emergency department, especially the effect on stress response and the effect on the acute confusional state. The investigators intend to conduct a randomized clinical trial in hip fracture patients years 65 and older presenting in the emergency department. In addition to standard analgesia with parenteral paracetamol, the first group of patients will receive fascia iliaca compartment block and the second group placebo. The investigators will monitor the effect of treatment protocol on laboratory parameters of stress response copeptin and cortisol, frequency and severity of acute confusional state, pain intensity and the need for additional opioid analgesics. Data obtained from this research could significantly improve the standard and quality of analgesia in the older patients with hip fracture. Regional anesthesia can diminish or prevent the development of stress response and cognitive impairment and these are the factors that complicate recovery of this fragile group of patients.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be blinded by sham procedure (disinfection, sting with blunt needle, (without piercing the skin), in the groin area, same place where actual FICB is given and covered with same gauze/patch). It will not be revealed to care providers and outcome measurement associate in which group participant is. After the data collection statistical analyst will not know is A group experimental or control.
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
- •hip fracture after minor trauma/simple falls, confirmed by imaging technique (X-ray or CT scan or MRI)
- •signed informed consent form (after a verbal explanation and written information sheet)
排除标准
- •pathological fracture
- •head injury
- •body mass bellow 50 kg
- •cognitive impairment (Abbreviated Mental Test Score less then 6 points)
- •oral anticoagulant drugs
- •prior drug allergy (paracetamol, tramadol, local anesthetics)
- •prior peripheral artery bypass surgery (on the same side as hip fracture)
- •skin or soft tissue infection in the groin area (on the same side as hip fracture)
- •simultaneously bilateral hip fracture
- •opioid analgesics prior to hospital arrival
研究组 & 干预措施
B (FICB)
Participants receiving fascia iliaca compartment block (FICB)
干预措施: fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml) (Procedure)
B (FICB)
Participants receiving fascia iliaca compartment block (FICB)
干预措施: paracetamol 1 gram IV (Drug)
B (FICB)
Participants receiving fascia iliaca compartment block (FICB)
干预措施: Rescue analgesic tramadol 100 mg IV if needed (Drug)
A (PLACEBO)
Participants receiving sham injection matching fascia iliaca compartment block (FICB)
干预措施: paracetamol 1 gram IV (Drug)
A (PLACEBO)
Participants receiving sham injection matching fascia iliaca compartment block (FICB)
干预措施: Rescue analgesic tramadol 100 mg IV if needed (Drug)
A (PLACEBO)
Participants receiving sham injection matching fascia iliaca compartment block (FICB)
干预措施: Sham injection (Procedure)
结局指标
主要结局
Stress Response 1
时间窗: Change from baseline cortisol plasma level at 24 hours
cortisol plasma level
Stress Response 2
时间窗: Change from baseline copeptin plasma level at 24 hours
copeptin plasma level
Acute confusional state/Delirium
时间窗: Change from baseline Abbreviated Mental Test Score at 24 hours
Abbreviated Mental Test Score (AMTS) - 10 point scale, from 0 to 10, 10 is the best possible result, 2 and more point drop from baseline indicating delirium
次要结局
- Pain Intensity(Immediately prior and 30, 120, 240 minutes and 24 hours)
研究者
Andela Simic
Principal Investigator
General Hospital Sveti Duh
