- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590782
Erector Spinae Plane Block for Acute Pain Management in the Emergency Department
Erector Spinae Plane Block for Acute Pain Management in Emergency Department Patients With Rib Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3A1R9
- Health Sciences Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pending (Pending)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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