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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04311827
Collaborator
Society for Academic Emergency Medicine (Other)
39
Enrollment
1
Location
21.9
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Serratus Anterior Plane Block

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 Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date :
Mar 3, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in pain score [Before and 3 hours after analgesia administration]

    Patient reported pain score from 0-10 (0 - no pain, 10 = worst pain imaginable).

  2. Change in incentive spirometry volume [Before and 3 hours after analgesia administration]

    Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device

Secondary Outcome Measures

  1. Analgesia administration [Up to 3 days]

    Dosage of analgesic medications administered for pain during ED visit and hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Hospital Palo Alto California United States 94305

Sponsors and Collaborators

  • Stanford University
  • Society for Academic Emergency Medicine

Investigators

  • Principal Investigator: Youyou Duanmu, MD, MPH, STANFORD HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Youyou Duanmu, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT04311827
Other Study ID Numbers:
  • 52801
First Posted:
Mar 17, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Fractures, Multiple

Study Results

No Results Posted as of Aug 25, 2022