Regional Anaesthesia for Painful Injuries After Disasters (RAPID)

June 13, 2017 updated by: Epicentre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Morphine
Intravenous injection of 0.1mg/kg of morphine
Drug: Bupivacaine (femoral nerve block)
0.5% bupivacaine
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
Device: Ultrasound
Drug: Morphine
Intravenous injection of 0.1mg/kg of morphine
Drug: Bupivacaine (femoral nerve block)
0.5% bupivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hours
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
24 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Epicentre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brown University
Medecins Sans Frontieres, Netherlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rebecca F Grais, PhD, Epicentre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Epicentre RAPID Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The trial dataset will be made publicly available at the conclusion of the trial.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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