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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06299137
Other study ID # RE2022-0000000349
Secondary ID RE2022-000000034
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date October 2025

Study information

Verified date February 2024
Source Rhode Island Hospital
Contact Leland K Perice, MD
Phone 4014293441
Email lperice@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are: - Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. - Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours. Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT - pain score of 5/10. - Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale - perform an incentive spirometry and be able to cough on command Exclusion Criteria: - isolated rib fractures that do not include ribs T3-T9 - penetrating trauma, pregnancy - requiring immediate surgical or procedural intervention - known allergy to amide-type local anesthetics - have a painful distracting injury

Study Design


Intervention

Procedure:
Serratus Anterior Plane Block
Patients who undergo randomization to the intervention arm will undergo the Serratus Anterior Plane Block.
Drug:
Ropivacaine injection
For the Serratus Anterior Plane Block, Ropivacaine will be used as the anesthetic.

Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2. — View Citation

Lin J, Hoffman T, Badashova K, Motov S, Haines L. Serratus Anterior Plane Block in the Emergency Department: A Case Series. Clin Pract Cases Emerg Med. 2020 Jan 21;4(1):21-25. doi: 10.5811/cpcem.2019.11.44946. eCollection 2020 Feb. — View Citation

Paul S, Bhoi SK, Sinha TP, Kumar G. Ultrasound-Guided Serratus Anterior Plane Block for Rib Fracture-Associated Pain Management in Emergency Department. J Emerg Trauma Shock. 2020 Jul-Sep;13(3):208-212. doi: 10.4103/JETS.JETS_155_19. Epub 2020 Sep 18. — View Citation

Sarode AL, Ho VP, Pieracci FM, Moorman ML, Towe CW. The financial burden of rib fractures: National estimates 2007 to 2016. Injury. 2021 Aug;52(8):2180-2187. doi: 10.1016/j.injury.2021.05.027. Epub 2021 May 19. — 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PIC Score Determine if the SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. The PIC score is a scoring system that can be measured serially in patients with rib fractures to assess pulmonary function and to prognosticate clinical outcomes. 5 hours
Secondary Total oral morphine equivalents over the first 24 hours Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours. 24 hours
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