Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures

Opioid Use Clinical Trial

Official title:

Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures,

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
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Opioid Use
• Pain Acute
• Regional Anesthesia
• Rib Fractures

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