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US-guided SAPB for Rib Fractures in the ED

Primary Purpose

Rib Fractures, Rib Fracture Multiple

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine

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

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring Nerve Block, Serratus Anterior Plane Block, Ultrasound, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alameda Health System - Highland HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental (SAPB)

Control

Arm Description

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

Patients randomized to the control arm receive usual pain control treatment in the emergency department.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Successful analgesia for block group

Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.

Non-opioid medications given (yes/no)

NSAID, APAP, Gabapentin administered in block versus control groups.

Adverse events

Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.

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).

Full Information

NCT ID

NCT03619785

First Posted

July 13, 2018

Last Updated

December 14, 2018

Sponsor

Andrew A Herring

Collaborators

Oregon Health and Science University, University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03619785

Brief Title

US-guided SAPB for Rib Fractures in the ED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 6, 2018 (Actual)

Primary Completion Date

August 31, 2019 (Anticipated)

Study Completion Date

August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew A Herring

Collaborators

Oregon Health and Science University, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rib Fractures, Rib Fracture Multiple

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental (SAPB)

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Patients randomized to the control arm receive usual pain control treatment in the emergency department.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Oral or IV pain medication as needed.

Primary Outcome Measure Information:

Title

Change in Numeric Pain Rating Scale score between time 0 and time 60 when comparing block and control groups

Description

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

20, 40, 60 minutes

Title

Difference in total morphine equivalents

Description

Time Frame

1, 4, 12, and 24 hours

Title

Successful analgesia for block group

Description

Successful analgesia at 20, 40 and 60 minutes: Proportion of patients not receiving morphine dosing.

Time Frame

20, 40, 60 minutes

Title

Non-opioid medications given (yes/no)

Description

NSAID, APAP, Gabapentin administered in block versus control groups.

Time Frame

20, 40, 60 minutes

Title

Adverse events

Description

Proportion of patients with new onset of seizure, arrhythmias, hyper or hypotension (SBP<90 or >180), hypoxia, nausea, lightheadedness, vomiting.

Time Frame

60 minutes

Title

Sensory testing

Description

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Herring

Phone

510-633-7498

aherring@alamedahealthsystem.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Sun

Phone

510-437-8364

jennsun@alamedahealthsystem.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Herring, MD

Organizational Affiliation