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

NCT06299137 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: RE2022-0000000349
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Acute; Regional Anesthesia; Opioid Use; Rib Fractures

Keywords

rib fractures; regional anesthesia; Opioid use; acute pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total oral morphine equivalents over the first 24 hours

  24 hours

Study Arms (2)

Control

NO INTERVENTION

Usual care. No changes made or recommended to patients randomized to the control arm.

Intervention arm (Undergoes SAPB)

EXPERIMENTAL

Patients randomized to this arm will receive the Serratus Anterior Plane block.

Procedure: Serratus Anterior Plane Block; Drug: Ropivacaine injection

Interventions

Serratus Anterior Plane Block PROCEDURE

Patients who undergo randomization to the intervention arm will undergo the Serratus Anterior Plane Block.

Intervention arm (Undergoes SAPB)

Ropivacaine injection DRUG

For the Serratus Anterior Plane Block, Ropivacaine will be used as the anesthetic.

Also known as: Ropivacaine

Intervention arm (Undergoes SAPB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (5)

• 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.

  PMID: 33304071 BACKGROUND

• 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.

  PMID: 35106815 BACKGROUND

• 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.

  PMID: 32064417 BACKGROUND

• 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: 30020155 BACKGROUND

• 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.

  PMID: 34059325 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Acute Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistants who collect the data will be blinded to which arm of the study the participants are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)