Recruiting

Ultrasound Guided Block

Sponsor:

WellSpan Health

Code:

NCT05748366

Conditions

Rib Fracture Multiple

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Serratus Anterior Plane Block (SAPB)

Standard Analgesic Medications

Study Details

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. 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. Assess the safety and feasibility of performing ultrasound-guided SAPB in the ED.
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

Study ID

NCT05748366

Start date

Mar 31, 2023

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Serratus Anterior Plane Block

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

active comparator: Standard Analgesic Medications

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

Interventions

Serratus Anterior Plane Block (SAPB)

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.

Standard Analgesic Medications

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

Primary outcome measure

  • Visual Analog Pain Score (VAS) at 2 hours [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Daniel Kreider, MD

717-851-5817dkreider3@wellspan.org

Brent Becker, MD

717-851-4819bbecker2@wellspan.org

Locations

Wellspan Health York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Brent A Becker, MD

2402161109bbecker2@wellspan.org

More Information

Sponsor

WellSpan Health

Last update posted

Jul 18, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellSpan Health on 2025-07-18.