NCT04311827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

March 10, 2020

Last Update Submit

August 23, 2022

Conditions

Rib Fracture Multiple

Outcome Measures

Primary Outcomes (2)

  • Change in pain score

    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

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

    Before and 3 hours after analgesia administration

Secondary Outcomes (1)

  • Analgesia administration

    Up to 3 days

Study Arms (2)

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

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

Interventions

Serratus Anterior Plane BlockOTHER

Injection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line

Serratus anterior plane block and traditional analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Posterior rib fractures
  • Bilateral rib fractures
  • Sternal fracture
  • Known allergy to local anesthetics
  • Pregnancy
  • Significant coagulopathy
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (10)

  • Luftig J, Mantuani D, Herring AA, Dixon B, Clattenburg E, Nagdev A. Successful emergency pain control for posterior rib fractures with ultrasound-guided erector spinae plane block. Am J Emerg Med. 2018 Aug;36(8):1391-1396. doi: 10.1016/j.ajem.2017.12.060. Epub 2017 Dec 28.

    PMID: 29301653BACKGROUND

  • Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22.

    PMID: 21256488BACKGROUND

  • Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.

    PMID: 27533913BACKGROUND

  • Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.

    PMID: 16269301BACKGROUND

  • Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f.

    PMID: 21716105BACKGROUND

  • Thiruvenkatarajan V, Cruz Eng H, Adhikary SD. An update on regional analgesia for rib fractures. Curr Opin Anaesthesiol. 2018 Oct;31(5):601-607. doi: 10.1097/ACO.0000000000000637.

    PMID: 30020155BACKGROUND

  • Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.

    PMID: 30740657BACKGROUND

  • Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. No abstract available.

    PMID: 27595172BACKGROUND

  • Todd SR, McNally MM, Holcomb JB, Kozar RA, Kao LS, Gonzalez EA, Cocanour CS, Vercruysse GA, Lygas MH, Brasseaux BK, Moore FA. A multidisciplinary clinical pathway decreases rib fracture-associated infectious morbidity and mortality in high-risk trauma patients. Am J Surg. 2006 Dec;192(6):806-11. doi: 10.1016/j.amjsurg.2006.08.048.

    PMID: 17161098BACKGROUND

  • Martin TJ, Eltorai AS, Dunn R, Varone A, Joyce MF, Kheirbek T, Adams C Jr, Daniels AH, Eltorai AEM. Clinical management of rib fractures and methods for prevention of pulmonary complications: A review. Injury. 2019 Jun;50(6):1159-1165. doi: 10.1016/j.injury.2019.04.020. Epub 2019 Apr 22.

    PMID: 31047683BACKGROUND

Study Officials

  • Youyou Duanmu, MD, MPH

    STANFORD HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 17, 2020

Study Start

March 3, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)