The Erector Spinae Plane Block and Its Effect on Respiratory Status and Pain Management in Rib Fracture Patients

NCT ID: NCT03805360

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2020-01-10

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.

Conditions

Rib Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ESP block with normal saline

An erector spinae plane block will be performed and a single dose of Normal Saline Flush, 0.9% Injectable Solution will be administered into the target muscle plane.

Group Type: SHAM_COMPARATOR

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type: DRUG

Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.

ESP block with local anesthetic

An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.

Interventions

Ropivacaine

Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.

Intervention Type: DRUG

Normal Saline Flush, 0.9% Injectable Solution

Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.

Intervention Type: DRUG

Other Intervention Names

Local anesthetic; 0.9% Sodium Chloride

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryant Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM20014264

Identifier Type: -

Identifier Source: org_study_id