Rib Fracture Multiple Clinical Trial
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.
NCT number | NCT04311827 |
Other study ID # | 52801 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2020 |
Est. completion date | December 31, 2021 |
Verified date | August 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University Hospital | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Society for Academic Emergency Medicine |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Analgesia administration | Dosage of analgesic medications administered for pain during ED visit and hospital stay | Up to 3 days |
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