Regional Anaesthesia for Painful Injuries After Disasters (RAPID)

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.

Study Overview

• Status: Withdrawn
• Conditions: Fracture; Lower Limb Injuries
• Intervention / Treatment: Device: Ultrasound; Drug: Morphine; Drug: Bupivacaine (femoral nerve block)

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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Standard of Care; Intravenous injection of 0.1mg/kg of morphine. Injection of 5cc of 0.9% normal saline into the subcutaneous tissue of the thigh.	Drug: Morphine; Intravenous injection of 0.1mg/kg of morphine
Active Comparator: Femoral nerve block; Intravenous injection of 0.1mg/kg of morphine. Injection of 20cc of 0.5% bupivacaine into the fascia iliaca space using standard anatomic landmarks.	Drug: Morphine; Intravenous injection of 0.1mg/kg of morphine; Drug: Bupivacaine (femoral nerve block); 0.5% bupivacaine
Active Comparator: Ultra-sound guided femoral nerve block; Intravenous injection of 0.1mg/kg of morphine.Injection of 20cc of 0.5% bupivacaine around their femoral nerve under direct ultrasound guidance	Device: Ultrasound; Drug: Morphine; Intravenous injection of 0.1mg/kg of morphine; Drug: Bupivacaine (femoral nerve block); 0.5% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Brown University; Medecins Sans Frontieres, Netherlands
• Investigators: Study Director: Rebecca F Grais, PhD, Epicentre

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: anesthesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: Epicentre RAPID Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial dataset will be made publicly available at the conclusion of the trial.