Lower Limb InjuriesPhase 4RAPIDNCT02698228
Regional Anaesthesia for Painful Injuries After Disasters
A Phase 4 study testing Bupivacaine (femoral nerve block), Morphine and Ultrasound in people with Lower Limb Injuries and Fracture, run by Epicentre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Injuries, Fracture
- What is being tested?
- Bupivacaine (femoral nerve block), Morphine and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries .
Who cannot join
- multi-system trauma
- severe respiratory distress
- hypotension
- altered mental status
- active infection at the sight of injection
- known current pregnancy
Show all 10Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Limb Injuries, Fracture
- Being tested
- Bupivacaine (femoral nerve block), Morphine, Ultrasound
- Keywords
- anesthesia
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine (femoral nerve block)Drug
0.5% bupivacaine
MorphineDrug
Intravenous injection of 0.1mg/kg of morphine
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: Bupivacaine (femoral nerve block); Drug: Morphine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
Analgesic requirements
Analgesic requirements will be recorded as the total amount of analgesic medication received during the full 24 hours of patient follow up.
Measured: 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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Study did not occur
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
- Investigators
- Rebecca F Grais, PhD, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698228
- Sponsor's protocol ID
- Epicentre RAPID Trial
- Acronym
- RAPID
- Status last verified
- Jun 2017
- First submitted
- 16 Feb 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The trial dataset will be made publicly available at the conclusion of the trial.
Publications
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.
PubMed 27842565
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anaesthesia for Painful Injuries After Disasters (RAPID) Study: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02698228
- Acronym / sponsor ID
- RAPID / Epicentre RAPID Trial
- Conditions
- Lower Limb Injuries, Fracture
- Keywords
- anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not occur
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Brown University, Medecins Sans Frontieres, Netherlands
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Sham comparator | Drug: MorphineIntravenous injection of 0.1mg/kg of morphine. Injection of 5cc of 0.9% normal saline into the subcutaneous tissue of the thigh. |
| Femoral nerve block | Active comparator | Drug: Bupivacaine (femoral nerve block), Drug: MorphineIntravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks. |
| Ultra-sound guided femoral nerve block | Active comparator | Drug: Bupivacaine (femoral nerve block), Drug: Morphine, Device: UltrasoundIntravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years or older) presenting to an MSF field hospital with one or more lower limb injuries .
Key exclusion criteria (10 listed)
- multi-system trauma
- severe respiratory distress
- hypotension
- altered mental status
- active infection at the sight of injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine (femoral nerve block)0.5% bupivacaine | Drug | Femoral nerve block, Ultra-sound guided femoral nerve block |
| MorphineIntravenous injection of 0.1mg/kg of morphine | Drug | Femoral nerve block, Standard of Care, Ultra-sound guided femoral nerve block |
| Ultrasound | Device | Ultra-sound guided femoral nerve block |
Primary outcome
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.
3 secondary outcomes
Analgesic requirements
Time frame: 24 hours
Patient satisfaction
Time frame: 24 hours
Serious Adverse Events
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 27842565Levine 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.
- Individual participant dataSharing planned: Yes. The trial dataset will be made publicly available at the conclusion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca F Grais, PhD study director
Epicentre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine (femoral nerve block), Morphine and Ultrasound in people with Lower Limb Injuries and Fracture, run by Epicentre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.