Regional Anaesthesia for Painful Injuries After Disasters (RAPID) Study: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Epicentre
- 主要终点
- Pain intensity
研究概览
简要总结
The goal of the RAPID study is to fundamentally transform the way serious injuries are managed after earthquakes and other disasters by introducing a novel and cost-effective method for pain control. The study will enroll patients in the aftermath of a major earthquake to determine whether regional anesthesia, either with or without ultrasound-guidance, can reduce suffering from lower limb injuries, the most common earthquake-related injury, above and beyond the current standard of care for pain control in these settings.
详细描述
The Regional Anaesthesia for Painful Injuries after Disasters (RAPID) study aims to evaluate whether regional anesthesia (RA), either with or without ultrasound (US) guidance, can reduce pain from earthquake-related lower limb injuries in a disaster setting. The proposed study is a blinded, randomized controlled trial among earthquake victims with serious lower extremity injuries in a resource-limited setting. After obtaining informed consent, study participants will be randomized in a 1:1:1 allocation to either: standard care (parenteral morphine at 0.1 mg/kg); standard care plus a landmark-guided fascia iliaca compartment block (FICB); or standard care plus an US-guided femoral nerve block. General practice humanitarian response providers who have undergone a focused training in RA will perform nerve blocks with 20 ml of 0.5% levobupivacaine. US sham activities will be used in the standard care and FICB arms and a normal saline injection will be given to the control group to blind both participants and non-research team providers. The primary outcome measure will be the summed pain intensity difference calculated using a standard 11-point numerical rating scale reported by patients over 24-hours of follow-up. Secondary outcome measures will include overall analgesic requirements, adverse events and participant satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries .
排除标准
- •multi-system trauma
- •severe respiratory distress
- •hypotension
- •altered mental status
- •active infection at the sight of injection
- •known current pregnancy
- •unable to provide informed consent.
- •known allergies to local anesthetic agents or narcotic pain medication
- •receiving antithrombotic therapy or with a preexisting coagulopathy
- •likely to receive regional anesthesia for alternative reasons within two hours of screening
研究组 & 干预措施
Femoral nerve block
Intravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks.
干预措施: Bupivacaine (femoral nerve block) (Drug)
Standard of Care
Intravenous injection of 0.1mg/kg of morphine. Injection of 5cc of 0.9% normal saline into the subcutaneous tissue of the thigh.
干预措施: Morphine (Drug)
Femoral nerve block
Intravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks.
干预措施: Morphine (Drug)
Ultra-sound guided femoral nerve block
Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance
干预措施: Bupivacaine (femoral nerve block) (Drug)
Ultra-sound guided femoral nerve block
Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance
干预措施: Morphine (Drug)
Ultra-sound guided femoral nerve block
Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance
干预措施: Ultrasound (Device)
结局指标
主要结局
Pain intensity
时间窗: 24 hours
The summed pain intensity difference (SPID), a widely used measure for assessing the efficacy of new methods for pain management will be administered before and 24 hours for all patients.
次要结局
- Patient satisfaction(24 hours)
- Analgesic requirements(24 hours)
- Serious Adverse Events(24 hours)