Clinical trial
Ultrasound Guided Serratus Anterior Plane Block Versus Standard Therapy for Analgesic Relief of Rib Fractures in the Emergency Department
Name
HE-2023-30
Description
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.
Trial arms
Trial start
2023-03-31
Estimated PCD
2025-03-31
Trial end
2025-06-30
Status
Recruiting
Treatment
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.
Arms:
Serratus Anterior Plane Block
Other names:
SAPB
Standard Analgesic Medications
Analgesic medications will be administered via the intravenous, intramuscular or oral route at the discretion of the medical treatment team.
Arms:
Serratus Anterior Plane Block, Standard Analgesic Medications
Size
60
Primary endpoint
Visual Analog Pain Score (VAS) at 2 hours
2 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-07-06
1 organization
1 product
1 indication
Organization
WellSpan HealthIndication
Rib Fracture