Regional Anaesthesia for Painful Injuries After Disasters

Fracture Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02698228
• Other study ID #: Epicentre RAPID Trial
• Status: Withdrawn
• Phase: Phase 4
• First received: February 16, 2016
• Last updated: June 13, 2017
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2017
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Leg Injuries
• Lower Limb Injuries
• Wounds and Injuries

Intervention

Drug:
• Bupivacaine (femoral nerve block)
0.5% bupivacaine
• Morphine
Intravenous injection of 0.1mg/kg of morphine

Device:
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Epicentre	Brown University, Medecins Sans Frontieres, Netherlands

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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