Ultrasound Guided Serratus Anterior Plane Block for Rib Fractures

NCT05748366 | Recruiting

• 1 other identifier: HE-2023-30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center, randomized controlled trial examining the effect of serratus anterior plane block (SAPB) on pain, PIC scores and other clinical outcomes in emergency department patients with multiple rib fractures in comparison to the use of analgesic medication alone. Objectives

1. 1.Compare SAPB performed in the ED setting to analgesic medication alone with regard to pain, respiratory status and PIC score of patients with multiple rib fractures.
2. 2.Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED.
3. 3.Evaluate outcomes of patients receiving the SAPB in the ED including amount of analgesic medications used, level of care required, need for upgrading level of care, and length of stay.

Conditions

Rib Fracture Multiple

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score (VAS) at 2 hours

  Change in pain score on a visual analog scale (VAS) at 2 hours following randomization to ultrasound guided SAPB or analgesic medication only.

  2 hours

Secondary Outcomes (6)

• Pain Score

  4 hours, 6 hours, 8 hours, and 12 hours following randomization

• Pain/Inspiratory Effort/Cough (PIC) Score

  4 hours, 6 hours, 8 hours, and 12 hours following randomization

• Morphine Milligrams Equivalent (MME)

  2 hours, 4 hours, 6 hours, 8 hours and 12 hours following randomization

• Length of Stay (hours)

  During index hospitalization following randomization

• Rate of ICU Utilization

  From date of randomization until the date of discharge from the hospital or death from any cause, whichever came first, assessed up to 100 months

Other Outcomes (1)

• Safety Outcomes

  30 days

Study Arms (2)

Serratus Anterior Plane Block

EXPERIMENTAL

Subjects will undergo serratus anterior plane block, in addition to standard of care analgesic medications at the discretion of the treatment team.

Procedure: Serratus Anterior Plane Block (SAPB); Drug: Standard Analgesic Medications

Standard Analgesic Medications

ACTIVE COMPARATOR

Subjects will receive standard of care analgesic medications at the discretion of the treatment team.

Drug: Standard Analgesic Medications

Interventions

Serratus Anterior Plane Block (SAPB) PROCEDURE

The ultrasound-guided serratus anterior plane block (SAPB) will be performed in a manner previously described in published medical literature. Patients will be consented and monitored. Bupivacaine 0.5% (5 mg/ml) diluted to 30-40 ml will be used in a dose not to exceed 2 mg/kg. The serratus anterior fascial plane will be identified in the 4th/5th intercostal space. The needle will be advanced under real-time ultrasound guidance targeting the superficial serratus anterior fascial plane. The procedure assistant will inject small volumes to hydrodissect the muscle bellies evenly under direct visualization, indicating local anesthetic spread within the fascial plane. Anesthetic will then be injected in 5 ml increments and the needle will be removed. Patient will be continuously monitored on telemetry and pulse-oximetry. Reassessment of the patient will continue for 30 minutes to monitor for signs of local anesthetic systemic toxicity.

Also known as: SAPB

Serratus Anterior Plane Block

Standard Analgesic Medications DRUG

Analgesic medications will be administered via the intravenous, intramuscular or oral route at the discretion of the medical treatment team.

Serratus Anterior Plane Block; Standard Analgesic Medications

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• \>1 Unilateral, acute rib fractures diagnosed on x-ray or CT imaging
• Patient presenting to the WellSpan York Hospital ED
• Patient requiring IV analgesia or oral opioid to control pain related to rib fractures

You may not qualify if:

• Age \<18 years
• Inability to provide informed consent
• Allergy to local anesthesia
• Subsequent visit for rib fractures
• Patients taken emergently to the OR or discharged from the ED
• Significant distracting injuries/polytrauma that would not be expected to be responsive to analgesia from SAPB and confound pain scores, i.e. long bone fractures, intraabdominal injuries, etc.

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

Wellspan Health York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (15)

• Southgate SJ, River GF, Herbst MK. Ultrasound-Guided Serratus Anterior Blocks. 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538476/

  PMID: 30860711 BACKGROUND

• Terry SM, Shoff KA, Sharrah ML. Improving Blunt Chest Wall Injury Outcomes: Introducing the PIC Score. J Trauma Nurs. 2021 Nov-Dec 01;28(6):386-394. doi: 10.1097/JTN.0000000000000618.

  PMID: 34766933 BACKGROUND

• Bass GA, Stephen C, Forssten MP, Bailey JA, Mohseni S, Cao Y, Chreiman K, Duffy C, Seamon MJ, Cannon JW, Martin ND. Admission Triage With Pain, Inspiratory Effort, Cough Score can Predict Critical Care Utilization and Length of Stay in Isolated Chest Wall Injury. J Surg Res. 2022 Sep;277:310-318. doi: 10.1016/j.jss.2022.04.001. Epub 2022 May 6.

  PMID: 35533604 BACKGROUND

• Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.

  PMID: 29766081 BACKGROUND

• Schnekenburger M, Mathew J, Fitzgerald M, Hendel S, Sekandarzad MW, Mitra B. Regional anaesthesia for rib fractures: A pilot study of serratus anterior plane block. Emerg Med Australas. 2021 Oct;33(5):788-793. doi: 10.1111/1742-6723.13724. Epub 2021 Jan 29.

  PMID: 33511786 BACKGROUND

• Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

  PMID: 23923989 BACKGROUND

• Nair A, Diwan S. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Managing Pain Due to Multiple Rib Fractures: A Scoping Review. Cureus. 2022 Jan 17;14(1):e21322. doi: 10.7759/cureus.21322. eCollection 2022 Jan.

  PMID: 35186581 BACKGROUND

• Davis K, Connor X. Single injection serratus anterior plane blocks for traumatic rib fractures. A good start but a missed opportunity. Am J Emerg Med. 2021 Dec;50:810. doi: 10.1016/j.ajem.2021.03.045. Epub 2021 Mar 14. No abstract available.

  PMID: 33745771 BACKGROUND

• Diwan S, Nair A. A retrospective study comparing analgesic efficacy of ultrasound-guided serratus anterior plane block versus intravenous fentanyl infusion in patients with multiple rib fractures. J Anaesthesiol Clin Pharmacol. 2021 Jul-Sep;37(3):411-415. doi: 10.4103/joacp.JOACP_349_19. Epub 2021 Oct 12.

  PMID: 34759553 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

• 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

• Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.

  PMID: 33383266 BACKGROUND

• Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.

  PMID: 11354213 BACKGROUND

• Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.

  PMID: 9835471 BACKGROUND

Study Officials

• Daniel Kreider, MD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Kreider, MD

CONTACT

717-851-5817; dkreider3@wellspan.org

Brent Becker, MD

CONTACT

717-851-4819; bbecker2@wellspan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Emergency Ultrasound, Principal Investigator

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 28, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)