Serratus Anterior Plane Block for Improving Pain and Respiratory Function in Patients With Multiple Rib Fractures

August 23, 2022 updated by: Youyou Duanmu, Stanford University

The Effect of the Serratus Anterior Plane Block in Improving Pain and Respiratory Function in Trauma Patients Presenting to the Emergency Department With Multiple Rib Fractures.

This is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. When resources are available for a SAPB to be performed, patients will receive this block in addition to traditional pain medications, while at other times, patients will receive traditional pain medications only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain management by systemic analgesics and by nerve blocks are both standard of care and used in Emergency Department (ED) depending on the resources available. Not all ED physicians are trained or comfortable with the serratus anterior nerve block and thus it is not always available to patients and is provider dependent.

This is an observational study where patients with multiple rib fractures will receive either a serratus anterior plane block (SAPB) in addition to traditional forms of pain control when providers trained to perform the block are available, or will receive traditional forms pain control if trained personnel are not available. In addition to the serratus anterior plane block, standard forms of pain control in the Stanford Emergency Department include: oral or parenteral acetaminophen, oral or parenteral NSAIDs, oral or parenteral opiates, parenteral lidocaine, and parenteral ketamine.

Retrospective evaluation of the allocation of patients to either nerve block or no nerve block will be dictated by physician ability, time and resources to do the block. The efficacy of the block will be evaluated by serial measurements of pain score and respiratory capacity.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be patients who are 18 years and older (of all genders and ethnic backgrounds) presenting to the Stanford University Emergency Department with multiple, acute, unilateral, antero-lateral rib fractures who meet inclusion/exclusion criteria

Description

Inclusion Criteria:

  1. Age greater or equal to 18 years of age
  2. Presentation to Stanford University Hospital Emergency Department within 12 hours of a traumatic incident
  3. Three or more anterior and/or lateral unilateral rib fractures diagnosed by CT
  4. GCS 15, with the ability to discern and describe pain from rib fractures and give consent
  5. Presentation to the Emergency Department between 7am and 11pm (for identification by research assistants)

Exclusion Criteria:

  1. Posterior rib fractures
  2. Bilateral rib fractures
  3. Sternal fracture
  4. Known allergy to local anesthetics
  5. Pregnancy
  6. Significant coagulopathy
  7. Hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serratus anterior plane block and traditional analgesia
Serratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed
Other: Serratus Anterior Plane Block
Injection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line
Traditional analgesia
Serratus anterior plane block (Bupivacaine 75mg injected into facial plane once) Acetaminophen 1000mg IV every 6 hours as needed Toradol 15mg IV every 6 hours as needed Morphine 4mg every 2 hours as needed Hydromorphone 0.5mg IV every 2 hours as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain score
Time Frame: Before and 3 hours after analgesia administration
Patient reported pain score from 0-10 (0 - no pain, 10 = worst pain imaginable).
Before and 3 hours after analgesia administration
Change in incentive spirometry volume
Time Frame: Before and 3 hours after analgesia administration
Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device
Before and 3 hours after analgesia administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia administration
Time Frame: Up to 3 days
Dosage of analgesic medications administered for pain during ED visit and hospital stay
Up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Society for Academic Emergency Medicine

Investigators

  • Principal Investigator: Youyou Duanmu, MD, MPH, Stanford hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 15, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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