NCT02698228

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

February 16, 2016

Last Update Submit

June 13, 2017

Conditions

Lower Limb InjuriesFracture

Keywords

anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Analgesic requirements

    24 hours

  • Patient satisfaction

    24 hours

  • Serious Adverse Events

    24 hours

Study Arms (3)

Standard of Care

SHAM COMPARATOR

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

Femoral nerve block

ACTIVE COMPARATOR

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)Drug: Morphine

Ultra-sound guided femoral nerve block

ACTIVE COMPARATOR

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)Drug: MorphineDevice: Ultrasound

Interventions

Bupivacaine (femoral nerve block)DRUG

0.5% bupivacaine

Femoral nerve blockUltra-sound guided femoral nerve block
MorphineDRUG

Intravenous injection of 0.1mg/kg of morphine

Femoral nerve blockStandard of CareUltra-sound guided femoral nerve block
UltrasoundDEVICE
Ultra-sound guided femoral nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Levine AC, Teicher C, Aluisio AR, Wiskel T, Valles P, Trelles M, Glavis-Bloom J, Grais RF. Regional Anesthesia for Painful Injuries after Disasters (RAPID): study protocol for a randomized controlled trial. Trials. 2016 Nov 14;17(1):542. doi: 10.1186/s13063-016-1671-z.

    PMID: 27842565DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

BupivacaineMorphineUltrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rebecca F Grais, PhD

    Epicentre

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

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