US-guided SAPB for Rib Fractures in the ED

Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)

The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

Study Overview

• Status: Unknown
• Conditions: Rib Fractures; Rib Fracture Multiple
• Intervention / Treatment: Drug: Bupivacaine; Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen

Detailed Description

Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94602
      • Recruiting
      • Alameda Health System - Highland Hospital
      • Contact: Jennifer Sun; Email: jennsun@alamedahealthsystem.org

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:

• Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
• Written informed consent must be obtained from each patient prior to entering the study.
• Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.

Exclusion Criteria:

• Patient refusal
• Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
• Patients deemed critically ill by provider
• Patients with decompensated psychiatric disorders
• Pregnant patients (positive urine or serum B-HCG)
• History of heart block or bradycardia
• History of uncontrolled seizures
• Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
• Patients with bilateral rib fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (SAPB); Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.	Drug: Bupivacaine; Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.
Active Comparator: Control; Patients randomized to the control arm receive usual pain control treatment in the emergency department.	Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen; Oral or IV pain medication as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups	Change in Numeric Pain Rating Scale scores between time 0 and time 60 between block and control groups: Numeric Pain Rating Scale score at 0 minutes minus Numeric Pain Rating Scale score at 60 minutes, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups	Change in Numeric Pain Rating Scale score for resting chest pain and dynamic chest pain at 20, 40, and 60 minutes between block and control groups, where a score of 0 is no pain and 10 is the worst pain the patient can imagine.	20, 40, 60 minutes
Difference in total morphine equivalents	Difference in total parenteral morphine equivalents received during study period (0 minutes to 60 minutes) and at 4, 12, and 24 hours (unless discharged from the hospital prior to 24 hours) in the block and control groups.	1, 4, 12, and 24 hours
Successful analgesia for block group	Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.	20, 40, 60 minutes
Non-opioid medications given (yes/no)	NSAID, APAP, Gabapentin administered in block versus control groups.	20, 40, 60 minutes
Adverse events	Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.	60 minutes
Sensory testing	Sensory testing to cold stimulus (alcohol swab) in the block group along the lateral sternal, anterior axillary, and posterior axillary lines at the levels of T2-T10 using a 3-point scale: 0 (unchanged), 1 (reduced), or 2 (no sensation).	60 minutes

Collaborators and Investigators

• Sponsor: Andrew A Herring
• Collaborators: University of California, Los Angeles; Oregon Health and Science University
• Investigators: Principal Investigator: Andrew Herring, MD, Alameda Health System - Highland Hospital; Principal Investigator: Josh Luftig, PA, Alameda Health System - Highland Hospital; Principal Investigator: Eben Clattenburg, MD, Alameda Health System - Highland Hospital; Principal Investigator: Daniel Mantuani, MD, MPH, Alameda Health System - Highland Hospital; Principal Investigator: Arun Nagdev, MD, Alameda Health System - Highland Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Emergency Department; Nerve Block; Serratus Anterior Plane Block
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Fractures, Bone; Rib Fractures; Fractures, Multiple; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Antimanic Agents; Respiratory System Agents; Antitussive Agents; Ketamine; Fentanyl; Gabapentin; Ketorolac; Acetaminophen; Bupivacaine; Morphine; Ibuprofen; Hydromorphone; Hydrocodone
• Other Study ID Numbers: 17-10102B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No