Clinical trial NCT03805360: The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
Official title: The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rib Fractures
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to identify the benefits of a type of nerve block, called an erector spinae plane block (ESP), in the treatment of patients with multiple rib fractures and uncontrolled pain despite receiving current institutional standards of care.

Detailed description: Rib fractures are one of the most common injuries secondary to blunt chest trauma, and carry significant risk in terms of patient morbidity and mortality. Pulmonary complications resulting from these injuries include severe atelectasis with hypoxemia, pneumonia, pleural effusions, respiratory distress syndrome, need for mechanical ventilation and ICU admission, and prolonged hospital stay. Many institutions have tried to develop protocols to risk stratify and appropriately treat these patients, with the goal of predicting those with higher likelihood of pulmonary complications in order to minimize additional morbidity. Studies have demonstrated critical spirometry values which correlate to worse patient outcomes; specifically, vital capacity less than 50% predicted, or less than 2L. Subsequently, there have been numerous attempts to identify the best treatment interventions for these high risk patients. In addition to multi-modal pain management, the most commonly used procedures include thoracic epidurals, continuous or single shot paravertebral blocks, and intercostal blocks. However, all of the above interventions carry significant risk, and the frequent use lovenox thromboprophylaxis drastically limit their use. Recently, a novel peripheral nerve block technique has been developed, an erector spinae plane block (ESP), which may provide similar or greater efficacy to the above, with significantly less risk to the patient.

Eligibility criteria: Inclusion Criteria:

* Blunt chest trauma
* Sustaining at least 3 unliateral rib fractures
* Resultant vital capacity less than 30% predicted
* Pain score reaches threshold despite using the current institutional standard of care for pain control

Exclusion Criteria:

* Patients whose weight less than 60kg.
* Patients with bilateral rib fractures.
* Patients that are intubated and mechanically ventilated.
* Pregnant Individuals.
* Any individual with a documented allergy to ropivacaine.
* Patients with limited English proficiency (LEP)
* Patients whose body habitus prevents the practitioner's ability to adequately perform the procedure.

Primary outcomes:
measure: Change in numeric pain score rating at rest (before incentive spirometry exercise)
timeFrame: Baseline and at 45 minutes after ESP block
measure: Change in numeric pain score rating with respiration (after incentive spirometry exercise)
timeFrame: Baseline and at 45 minutes after ESP block
measure: Change in incentive spirometry values
timeFrame: Baseline and at 45 minutes after ESP block
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bryant Tran, MD
role: PRINCIPAL_INVESTIGATOR
References: