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Regional Anaesthesia for Painful Injuries After Disasters (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698228
Recruitment Status : Withdrawn (Study did not occur)
First Posted : March 3, 2016
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
Brown University
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Epicentre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lower Limb Injuries Fracture Drug: Bupivacaine (femoral nerve block) Drug: Morphine Device: Ultrasound Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Regional Anaesthesia for Painful Injuries After Disasters (RAPID) Study: A Randomized Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Sham Comparator: 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.
Drug: Morphine
Intravenous injection of 0.1mg/kg of morphine

Active Comparator: 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.
Drug: Bupivacaine (femoral nerve block)
0.5% bupivacaine

Drug: Morphine
Intravenous injection of 0.1mg/kg of morphine

Active Comparator: 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
Drug: Bupivacaine (femoral nerve block)
0.5% bupivacaine

Drug: Morphine
Intravenous injection of 0.1mg/kg of morphine

Device: Ultrasound



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 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.


Secondary Outcome Measures :
  1. Analgesic requirements [ Time Frame: 24 hours ]
    Analgesic requirements will be recorded as the total amount of analgesic medication received during the full 24 hours of patient follow up.

  2. Patient satisfaction [ Time Frame: 24 hours ]
    All patients will be assessed at 24 hours for their overall satisfaction with their pain management on a standard Likert scale

  3. Serious Adverse Events [ Time Frame: 24 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698228


Sponsors and Collaborators
Epicentre
Brown University
Medecins Sans Frontieres, Netherlands
Investigators
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Study Director: Rebecca F Grais, PhD Epicentre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT02698228    
Other Study ID Numbers: Epicentre RAPID Trial
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The trial dataset will be made publicly available at the conclusion of the trial.
Keywords provided by Epicentre:
anesthesia
Additional relevant MeSH terms:
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Wounds and Injuries
Leg Injuries
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics