Erector Spinae Plane Block for Acute Pain Management in the Emergency Department

October 9, 2020 updated by: University of Manitoba

Erector Spinae Plane Block for Acute Pain Management in Emergency Department Patients With Rib Fractures

Rib fractures are a common cause of respiratory distress in trauma patients as poor pain control and subsequent hypoventilation commonly results in lung tissue collapse (atelectasis). The current mainstay of treatment in rib fractures are oral and intravenous opioids however these are often ineffective and can also precipitate hypoventilation. Recently there has been interest in regional anaesthesia techniques for managing painful conditions of the thorax as a way to avoid pain and opioid related hypoventilation. These techniques include ultrasound guided nerve blocks such as the intercostal, paravertebral and serratus anterior blocks. The use of these techniques is however limited by minimal dermatomal coverage as well as a high incidence of complications The erector spinae plane block is a new, very promising technique which offers a safe means of providing anaesthesia to a large part of the hemithorax with a single injection. The proposed study will seek to establish whether the erector spinae plane block can be successfully used in the emergency department for pain control in patients with acute rib fractures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rib fractures represent a significant cause of morbidity and mortality in trauma patients. Hypoventilation secondary to pain and altered breathing mechanics frequently leads to respiratory distress and may necessitate admission to an ICU. Currently, opioids are the mainstay of treatment in rib fracture pain management however they are often ineffective and themselves can also promote hypoventilation. A more effective means of analgesia in rib fractures is the use of regional anaesthesia techniques including ultrasound (US) guided nerve blocks. Multiple studies have shown promising results with the use of US guided intercostal nerve blocks, paravertebral blocks and serratus anterior blocks for acute and long-term pain control in rib fractures, however each of these techniques has significant drawbacks including being limited to single dermatomes, high incidence of complications, and incomplete analgesia of the hemithorax. Recently, the erector spinae plane block (ESPB) has come to the forefront as a potential safe and effective option for analgesia in painful conditions of the thorax. This technique involves identifying the erector spinae muscles at the level of a given thoracic transverse process and injecting local anaesthetic into the fascial plane (Figures 1, 2, and 3); the local anaesthetic then spreads through the fascial plane both cephalad and caudad to the injection point and will anaesthetize the thoracic sensory nerves that run in this plane at multiple dermatomal levels (Figure 4). Moreover, because the target point of injection is both superficial and protected by the bony transverse process the incidence of complications is felt to be low. While this technique has been successfully used in the field of anaesthesiology, the ESPB has yet to be integrated into the practice of emergency medicine physicians. In fact, only one paper has detailed it's use for acute pain control in the emergency department (ED; 7). Given the high morbidity associated with rib fractures, the inadequacy of opioid analgesia and the strong safety profile of the ESPB, the proposed study seeks to address whether this block can be used to provide analgesia in ED patients with acute rib fractures. This first study will provide proof of concept that this technique is a useful and safe technique for emergency providers to use.

Objectives To address whether the ESPB can successfully be used for analgesia in ED patients with rib fractures.

Hypothesis The investigators hypothesize that the ESPB will be a safe and effective means of analgesia in ED patients with rib fractures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute rib fractures failing traditional therapy.

Description

Inclusion Criteria:

  • Patients over the age of 18
  • Acute rib fractures with pain that is subjectively poorly controlled despite oral and/or intravenous opioids.

Exclusion Criteria:

  • Hemodynamic instability,
  • Active infection overlying the site of injection
  • Patients receiving anticoagulation
  • Patients with a history of a bleeding disorder
  • Patients with thrombocytopenia
  • Pregnant, are incarcerated
  • Decline the procedure
  • Inability to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analogue pain scale
Time Frame: 30-60 minutes
Pain scale with be taken pre- and post-block and regular intervals. The visual analogue pain scale ranges from 0-10, with 0 being no pain and 10 being the worse pain imaginable. Lower numerical scores are better for outcomes as it implies that the pain is more well managed.
30-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Ian Surdhar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pending (Other Grant/Funding Number: Edwards Lifesciences Corp.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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