Regional Anaesthesia for Painful Injuries After Disasters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Regional Anaesthesia for Painful Injuries After Disasters (RAPID) Study: A Randomized Trial

Conditions
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Lower Limb Injuries, Fracture

Intervention / Treatment
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* Drug: Bupivacaine (femoral nerve block)
* Drug: Morphine
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries . Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard of Care<br>Intravenous injection of 0.1mg/kg of morphine. Injection of 5cc of 0.9% normal saline into the subcutaneous tissue of the thigh. | Drug: Morphine<br>* Intravenous injection of 0.1mg/kg of morphine<br>|
| Active Comparator: Femoral nerve block<br>Intravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks. | Drug: Bupivacaine (femoral nerve block)<br>* 0.5% bupivacaine<br>Drug: Morphine<br>* Intravenous injection of 0.1mg/kg of morphine<br>|
| Active Comparator: Ultra-sound guided femoral nerve block<br>Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance | Drug: Bupivacaine (femoral nerve block)<br>* 0.5% bupivacaine<br>Drug: Morphine<br>* Intravenous injection of 0.1mg/kg of morphine<br>Device: Ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirements | Analgesic requirements will be recorded as the total amount of analgesic medication received during the full 24 hours of patient follow up. | 24 hours | 
| Patient satisfaction | All patients will be assessed at 24 hours for their overall satisfaction with their pain management on a standard Likert scale | 24 hours | 
| Serious Adverse Events | The investigators will monitor all patients for serious adverse events, including allergic reaction or local anesthetic systemic toxicity (LAST) from the regional anesthesia or respiratory depression or hypotension from narcotic pain medications | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia