Clinical trial NCT02698228: Regional Anaesthesia for Painful Injuries After Disasters
Official title: Regional Anaesthesia for Painful Injuries After Disasters (RAPID) Study: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lower Limb Injuries
Fracture
Keywords: anesthesia
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Brown University
name: Medecins Sans Frontieres, Netherlands
First posted: 2016-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain intensity
timeFrame: 24 hours
Secondary outcomes:
measure: Analgesic requirements
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24 hours
measure: Serious Adverse Events
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Epicentre
name: Rebecca F Grais, PhD
role: STUDY_DIRECTOR
References:
citation: 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.