Ultrasound Guided Serratus Anterior Plane Block for Rib Fractures

Part of paid clinical trials in York, Pennsylvania.

Sponsor
WellSpan Health
Study ID
NCT05748366
Status
Recruiting

Conditions

  • Rib Fracture Multiple

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Mar 31, 2023
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellspan Health York HospitalYorkPennsylvania17403
Brent A Becker, MD
2402161109

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