Rib FracturesNCT03590782
Erector Spinae Plane Block for Acute Pain Management in the Emergency Department
An observational study of Rib Fractures and Nerve Block, run by University of Manitoba at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Nerve Block
- What is being tested?
- Erector Spinae Block
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with acute rib fractures failing traditional therapy.
Who may be able to join
- Patients over the age of 18
- Acute rib fractures with pain that is subjectively poorly controlled despite oral and/or intravenous opioids.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rib Fractures, Nerve Block
- Being tested
- Erector Spinae Block
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae BlockOther
An ultrasound guided erector spinae block will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale
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.
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Mar 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Ian Surdhar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590782
- Sponsor's protocol ID
- Pending
- Status last verified
- Oct 2020
- First submitted
- 4 Jul 2018
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Acute Pain Management in Emergency Department Patients With Rib Fractures
- ClinicalTrials.gov ID
- NCT03590782
- Acronym / sponsor ID
- Pending
- Conditions
- Rib Fractures, Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Dr. Ian Surdhar
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute rib fractures failing traditional therapy.
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Acute rib fractures with pain that is subjectively poorly controlled despite oral and/or intravenous opioids.
Key exclusion criteria (8 listed)
- Hemodynamic instability,
- Active infection overlying the site of injection
- Patients receiving anticoagulation
- Patients with a history of a bleeding disorder
- Patients with thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae BlockAn ultrasound guided erector spinae block will be performed. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
Related trials for Rib Fractures
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures and Nerve Block, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain scale (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.