Regional Anesthesia for Painful Injuries after Disasters (RAPID): study protocol for a randomized controlled trial

BACKGROUND: Lower extremity trauma during earthquakes accounts for the largest burden of disaster-related injuries. Insufficient pain management is common in resource-limited disaster settings, and regional anesthesia (RA) may reduce pain in injured patients beyond current standards of care. To date, no controlled trials have been conducted to evaluate the use of RA for pain management in a disaster setting. METHODS/DESIGN: The Regional Anesthesia 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 equivalence 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 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 nonresearch 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 h of follow-up. Secondary outcome measures will include overall analgesic requirements, adverse events, and participant satisfaction. DISCUSSION: Given the high burden of lower extremity injuries in the aftermath of earthquakes and the currently limited treatment options, research into adjuvant interventions for pain management of these injuries is necessary. While anecdotal reports on the use of RA for patients injured during earthquakes exist, no controlled studies have been undertaken. If demonstrated to be effective in a disaster setting, RA has the potential to significantly assist in reducing both acute suffering and long-term complications for survivors of earthquake trauma. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02698228), registered on 16 February 2016.