US-guided SAPB for Rib Fractures in the ED

NCT03619785 | Unknown Phase 4 FDA Drug

• 1 other identifier: 17-10102B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rib Fractures; Rib Fracture Multiple

Keywords

Nerve Block; Serratus Anterior Plane Block; Ultrasound; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups

  20, 40, 60 minutes

• Difference in total morphine equivalents

  1, 4, 12, and 24 hours

• Successful analgesia for block group

  20, 40, 60 minutes

• Non-opioid medications given (yes/no)

  20, 40, 60 minutes

• Adverse events

  60 minutes

Study Arms (2)

Experimental (SAPB)

EXPERIMENTAL

Patients randomized to the experimental arm receive an ultrasound-guided serratus anterior plane block for their rib fracture pain.

Drug: Bupivacaine

Control

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

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.

Experimental (SAPB)

Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen DRUG

Oral or IV pain medication as needed.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew A Herring: lead
• Oregon Health and Science University: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Alameda Health System - Highland Hospital

Oakland, California, 94602, United States

RECRUITING

MeSH Terms

Conditions

Rib Fractures; Emergencies

Interventions

Bupivacaine; Fentanyl; Morphine; Hydromorphone; Hydrocodone; Acetaminophen; Ketorolac; Gabapentin; Ketamine; Ibuprofen

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Acetanilides; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Phenylpropionates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Herring

CONTACT

510-633-7498; aherring@alamedahealthsystem.org

Jennifer Sun

CONTACT

510-437-8364; jennsun@alamedahealthsystem.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Director, Department of Emergency Medicine, Highland Hospital

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 8, 2018
• Study Start: November 6, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)