US-guided SAPB for Rib Fractures in the ED

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Andrew Herring; 510-633-7498; aherring@alamedahealthsystem.org

Contact: Jennifer Sun; 510-437-8364; jennsun@alamedahealthsystem.org

Locations

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

• 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

More Information

• 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
• Last Update Posted: December 19, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Fractures, Bone; Rib Fractures; Fractures, Multiple; Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Acetaminophen; Ibuprofen; Ketorolac; Fentanyl; Ketamine; Morphine; Gabapentin; Hydromorphone; Hydrocodone; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action