US-guided SAPB for Rib Fractures in the ED

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03619785
• Other study ID #: 17-10102B
• Status: Recruiting
• Phase: Phase 4
• Start date: November 6, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2018
• Source: Alameda Health System
• Contact: Andrew Herring
• Phone: 510-633-7498
• Email: aherring[@]alamedahealthsystem.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures

Intervention

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.
• Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen
Oral or IV pain medication as needed.

Locations

Country	Name	City	State
United States	Alameda Health System - Highland Hospital	Oakland	California

Sponsors (3)

Lead Sponsor	Collaborator
Andrew A Herring	Oregon Health and Science University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Successful analgesia for block group	Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.	20, 40, 60 minutes
Secondary	Non-opioid medications given (yes/no)	NSAID, APAP, Gabapentin administered in block versus control groups.	20, 40, 60 minutes
Secondary	Adverse events	Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.	60 minutes
Secondary	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