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

Primary Purpose

Rib Fractures

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Normal Saline Flush, 0.9% Injectable Solution
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

ESP block with normal saline

ESP block with local anesthetic

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in numeric pain score rating at rest (before incentive spirometry exercise)
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
Change in incentive spirometry values
Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
August 5, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03805360
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The study aims to assess the systemic absorption of ropivacaine when it is administered into the erector spinae plane compartment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP block with normal saline
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
ESP block with local anesthetic
Arm Type
Experimental
Arm Description
An erector spinae plane block will be performed and a single dose of 0.5% ropivacaine will be injected into the target muscle plane.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
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
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Other Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.
Primary Outcome Measure Information:
Title
Change in numeric pain score rating at rest (before incentive spirometry exercise)
Description
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed before the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10= worst pain possible)
Time Frame
Baseline and at 45 minutes after ESP block
Title
Change in numeric pain score rating with respiration (after incentive spirometry exercise)
Description
Self-reported pain intensity before the ESP block is performed and after the ESP block is performed. These measurements will be assessed after the incentive spirometry exercise. Each item is scored 0-10 (0 = no pain; 10 = worst pain possible)
Time Frame
Baseline and at 45 minutes after ESP block
Title
Change in incentive spirometry values
Description
Incentive spirometry values, measured in cubic centimeters, when the participant provides one inhalational breath at maximum effort. The first measurement will be taken before the ESP block procedure and the second measurement 45 minutes after the ESP block procedure.
Time Frame
Baseline and at 45 minutes after ESP block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryant Tran, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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

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