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US-guided SAPB for Rib Fractures in the ED

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ClinicalTrials.gov Identifier: NCT03619785
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Oregon Health and Science University
University of California, Los Angeles
Information provided by (Responsible Party):
Andrew A Herring, Alameda Health System

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.

Condition or disease Intervention/treatment Phase
Rib Fractures Rib Fracture Multiple Drug: Bupivacaine Drug: Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED)
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups [ Time Frame: 60 minutes ]
    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.


Secondary Outcome Measures :
  1. Change in Numeric Pain Rating Scale score at rest versus when taking a deep breath when comparing block and control groups [ Time Frame: 20, 40, 60 minutes ]
    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.

  2. Difference in total morphine equivalents [ Time Frame: 1, 4, 12, and 24 hours ]
    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.

  3. Successful analgesia for block group [ Time Frame: 20, 40, 60 minutes ]
    Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.

  4. Non-opioid medications given (yes/no) [ Time Frame: 20, 40, 60 minutes ]
    NSAID, APAP, Gabapentin administered in block versus control groups.

  5. Adverse events [ Time Frame: 60 minutes ]
    Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.

  6. Sensory testing [ Time Frame: 60 minutes ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619785


Contacts
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Contact: Andrew Herring 510-633-7498 aherring@alamedahealthsystem.org
Contact: Jennifer Sun 510-437-8364 jennsun@alamedahealthsystem.org

Locations
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United States, California
Alameda Health System - Highland Hospital Recruiting
Oakland, California, United States, 94602
Contact: Jennifer Sun       jennsun@alamedahealthsystem.org   
Sponsors and Collaborators
Andrew A Herring
Oregon Health and Science University
University of California, Los Angeles
Investigators
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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
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Responsible Party: Andrew A Herring, Associate Research Director, Department of Emergency Medicine, Highland Hospital, Alameda Health System
ClinicalTrials.gov Identifier: NCT03619785    
Other Study ID Numbers: 17-10102B
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew A Herring, Alameda Health System:
Nerve Block
Serratus Anterior Plane Block
Ultrasound
Emergency Department
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Fractures, Multiple
Wounds and Injuries
Thoracic Injuries
Multiple Trauma
Acetaminophen
Ibuprofen
Ketorolac
Fentanyl
Morphine
Hydromorphone
Hydrocodone
Ketamine
Gabapentin
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents