Regional Anaesthesia for Painful Injuries After Disasters (RAPID)

Epicentre

Status and phase: Withdrawn; Phase 4

Conditions: Lower Limb Injuries; Fracture

Treatments: Drug: Bupivacaine (femoral nerve block); Device: Ultrasound; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02698228

Epicentre RAPID Trial

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Standard of Care

Sham Comparator group

Description:

Intravenous injection of 0.1mg/kg of morphine. Injection of 5cc of 0.9% normal saline into the subcutaneous tissue of the thigh.

Treatment:

Drug: Morphine

Femoral nerve block

Active Comparator group

Description:

Intravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks.

Treatment:

Drug: Morphine

Drug: Bupivacaine (femoral nerve block)

Ultra-sound guided femoral nerve block

Active Comparator group

Description:

Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance

Treatment:

Drug: Morphine

Device: Ultrasound

Drug: Bupivacaine (femoral nerve block)