Rib Fracture MultipleNCT04892563
Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department
A study testing Erector Spinae Plane Block and IV Analgesia in people with Rib Fracture Multiple, run by University of Southern California.
Trial summary
Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fracture Multiple
- What is being tested?
- Erector Spinae Plane Block and IV Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Aug 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18
- At least 1 acute rib fracture. Acute defined as within 7 days of presentation.
- Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure.
- Admitted to hospital for at least 24 hours of observation.
- Be able to consent and participate in study by assuming necessary positioning for intervention
Who cannot join
- Hypotension/shock (shock index >1.0, SBP < 90)
- Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.)
- Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar)
- Known hypersensitivity to local anesthetic
- Evidence of infection at the proposed site of injection
Trial locations and contacts
No sites are listed yet.
About this study
Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia.
Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections.
There have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.
Read the detailed description
Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. Additionally, even short courses can predispose to life-long addiction perpetuating the opioid epidemic. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently. As an example, ultrasound-guided peripheral nerve blocks for hip fractures have a promising track record for reducing opioid use and improving pain scores. The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. It was first described in 2016 by Forero, et al., as an effective alternative to traditional neuraxial blockade for post-operative and chronic thoracic pain. A recent literature review by Kot et al., 2019 revealed six prospective studies in post-operative patients concluding that the ESPB was at least as effective as opioids in thoracic pain reduction, easy to use and with a low complication rate. One prospective study in post-operative breast surgery patients demonstrated a reduction in morphine by 65% compared to control. Most literature on the ESPB in the ED are case reports, which demonstrate its versatility in a myriad of clinical situations such as renal colic, acute herpes zoster, acute transverse process fractures, extensive burns, mechanical back pain, acute pancreatitis and acute rib fractures. This review found the ESPB to be effective at reducing pain scores for all reported indications with no complications. The ESPB is a particularly attractive multimodal form of analgesia in the ED where acute traumatic rib fractures are a common presentation. Usually the involuntary splinting from acute pain results in the typical pulmonary complications, but high doses of opioids and the subsequent respiratory depressive effects can lead to higher rates of atelectasis, pneumonia and respiratory failure. In order to combat this "between a rock and a hard place" scenario, regional analgesia has emerged as an effective means of improving both pain respiratory mechanics. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. Another consideration of these technically more difficult procedures is that they are relatively contraindicated in the anticoagulated patient precluding a substantial number of elderly patients from their therapeutic benefits. The aforementioned reviews have supported the safety of the ESPB with no complications reported. Specifically, of the 10 case reports utilizing this block in the ED, none reported any complications. The 3 cases reported by Luftig et al, in 2018 specific to ED management of acute rib fractures were technically feasible, highly efficacious and safe. However, there have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, the investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.
- Conditions
- Rib Fracture Multiple
- Being tested
- Erector Spinae Plane Block, IV Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Also called Nerve Block, Erector Spinae Block
Nerve block with local anesthetic in the erector spinae plane
IV AnalgesiaDrug
Also called Morphine, Opioid
IV analgesia, typically Morphine/Opioid medications
| Study group | Role | What they receive |
|---|---|---|
| ESPB Block | Experimental | Patients with rib fracture randomized to block group Receives: Procedure: Erector Spinae Plane Block |
| Standard Care | Active comparator | Patients with rib fracture receiving IV analgesia/standard care Receives: Drug: IV Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale
Change in pain level from fractures as measured using a visual analog scale
Measured: 0, 1, 2 and 24 hours assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib Fracture MultipleStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Sajed, University of Southern California
- Investigators
- Tom Mailhot, MD, Principal investigator, LAC+USC Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892563
- Sponsor's protocol ID
- HS-21-00066
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Rib Fracture Analgesia in the Emergency Department
- ClinicalTrials.gov ID
- NCT04892563
- Acronym / sponsor ID
- HS-21-00066
- Conditions
- Rib Fracture Multiple
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 19 May 2021 (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, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia.
Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections.
There have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.
Detailed description
Rib fractures, while in isolation are self-limited and benign, can be exquisitely painful. Poorly controlled rib fracture pain can compromise respiratory function leading to increased morbidity and mortality, especially in the elderly. Currently, opioid medications are the mainstay of analgesia but are associated with significant adverse effects, such as respiratory depression and delirium. Additionally, even short courses can predispose to life-long addiction perpetuating the opioid epidemic. In an effort to improve acute pain in the ED and concomitantly reduce opioid use, ultrasound-guided regional anesthesia has been implemented more frequently. As an example, ultrasound-guided peripheral nerve blocks for hip fractures have a promising track record for reducing opioid use and improving pain scores. The erector spinae plane block (ESPB) is a relatively new ultrasound-guided procedure for thoracic analgesia. It was first described in 2016 by Forero, et al., as an effective alternative to traditional neuraxial blockade for post-operative and chronic thoracic pain. A recent literature review by Kot et al., 2019 revealed six prospective studies in post-operative patients concluding that the ESPB was at least as effective as opioids in thoracic pain reduction, easy to use and with a low complication rate. One prospective study in post-operative breast surgery patients demonstrated a reduction in morphine by 65% compared to control. Most literature on the ESPB in the ED are case reports, which demonstrate its versatility in a myriad of clinical situations such as renal colic, acute herpes zoster, acute transverse process fractures, extensive burns, mechanical back pain, acute pancreatitis and acute rib fractures. This review found the ESPB to be effective at reducing pain scores for all reported indications with no complications. The ESPB is a particularly attractive multimodal form of analgesia in the ED where acute traumatic rib fractures are a common presentation. Usually the involuntary splinting from acute pain results in the typical pulmonary complications, but high doses of opioids and the subsequent respiratory depressive effects can lead to higher rates of atelectasis, pneumonia and respiratory failure. In order to combat this "between a rock and a hard place" scenario, regional analgesia has emerged as an effective means of improving both pain respiratory mechanics. Previously, the serratus anterior plane (SAP) block has been used for this indication. However, typical anatomical distribution limits the effectiveness of the SAP block to anterior rib fractures, while the majority of traumatic rib fractures are posterior, thus require a more central blockade such as the proposed ESPB. The ESPB can be done as a single injection into the superficial structures of the back under ultrasound guidance and as such, is a both a relatively safe and technically easy procedure to perform, especially in comparison to the more traditional alternatives of epidurals, paravertebral and intercostal injections. Another consideration of these technically more difficult procedures is that they are relatively contraindicated in the anticoagulated patient precluding a substantial number of elderly patients from their therapeutic benefits. The aforementioned reviews have supported the safety of the ESPB with no complications reported. Specifically, of the 10 case reports utilizing this block in the ED, none reported any complications. The 3 cases reported by Luftig et al, in 2018 specific to ED management of acute rib fractures were technically feasible, highly efficacious and safe. However, there have been no prospective studies evaluating the efficacy and safety of the ESPB in the emergency department setting for acute rib fractures. The investigators hypothesize that the ESPB will provide improved acute pain scores in the emergency department compared to parental analgesia alone. Secondarily, the investigators hypothesize that this will translate to less inpatient opioid requirements and improved incentive spirometry values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Block | Experimental | Procedure: Erector Spinae Plane BlockPatients with rib fracture randomized to block group |
| Standard Care | Active comparator | Drug: IV AnalgesiaPatients with rib fracture receiving IV analgesia/standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18
- At least 1 acute rib fracture. Acute defined as within 7 days of presentation.
- Numerical pain score on presentation at least 5 out of 10. This will identify patients that justify the invasive procedure.
- Admitted to hospital for at least 24 hours of observation.
- Be able to consent and participate in study by assuming necessary positioning for intervention
Key exclusion criteria (5 listed)
- Hypotension/shock (shock index >1.0, SBP < 90)
- Distracting injury not amenable to ESPB as determined by the enrolling physician. (i.e extremity fracture, burn, laceration, contusion, joint dislocation, etc.)
- Examples of patients not able to consent/participate are intubated patients or patients in spinal precautions (i.e c-collar)
- Known hypersensitivity to local anesthetic
- Evidence of infection at the proposed site of injection
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 Plane BlockAlso: Nerve Block, Erector Spinae BlockNerve block with local anesthetic in the erector spinae plane | Procedure or surgery | ESPB Block |
| IV AnalgesiaAlso: Morphine, OpioidIV analgesia, typically Morphine/Opioid medications | Drug | Standard Care |
Primary outcome
To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale
Time frame: 0, 1, 2 and 24 hours assessment
Change in pain level from fractures as measured using a visual analog scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No
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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.
Tom Mailhot, MD principal investigator
LAC+USC Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and IV Analgesia in people with Rib Fracture Multiple, run by University of Southern California.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Sajed (858 361 4685, sajed@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effectiveness of the ESPB for pain management of acute rib fractures in the emergency department using a 10 point isual analog scale (time frame: 0, 1, 2 and 24 hours assessment). 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 19 May 2021.