Ultrasound Guided Serratus Anterior Plane Block for Rib Fractures

ConditionRib Fracture Multiple

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWellSpan Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years

Inability to provide informed consent

Allergy to local anesthesia

Subsequent visit for rib fractures

Trial design

Design model

Parallel

Treatments tested in this trial

Serratus Anterior Plane Block (SAPB)
Procedure/Surgery
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Serratus Anterior Plane BlockExperimental treatment 2 interventions

Group B: Standard Analgesic MedicationsActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

2 hours

Secondary outcomes

Pain Score

Numerical pain score (0-10 scale) at 4 hours, 6 hours, 8 hours, and 12 hours following randomization

Time frame

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

Pain/Inspiratory Effort/Cough (PIC) Score

PIC score (0-10 scale) at 4 hours, 6 hours, 8 hours, and 12 hours following

Time frame

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

Morphine Milligrams Equivalent (MME)

Morphine milligram equivalents (MME) of analgesia consumed at 2 hours, 4 hours, 6 hours, 8 hours and 12 hours following randomization

Time frame

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

Length of Stay (hours)

Emergency department, hospital and ICU lengths of stay

Time frame

During index hospitalization following randomization

Other outcomes

Safety Outcomes

Adverse outcomes related to serratus anterior plane block, including systemic toxicity, infection, pneumothorax, nerve injury or other complications.

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WellSpan Health

Lead sponsor

Source ClinicalTrials.gov

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