Rib FracturesSUETHE-RibsNCT05069961
Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
A study testing ESPB and TEA in people with Rib Fractures, run by Indiana University.
Trial summary
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rib Fractures
- What is being tested?
- ESPB and TEA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2023to 31 Jul 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Radiological evidence of 3 or more rib fractures
- Within 48 hours of admission to hospital with rib fractures
- Can actively participate by answering questions during TEA or ESPB placement
- Moderate-severe (4-10 out of 10) pain at the time of enrollment
Who cannot join
- Greater than 48 hrs since admission to the hospital with rib fractures
- Patient refusal
- Prisoner
- Infection at the site of TEA or ESPB insertion
- Allergy to local anesthetics
- Depth from skin to catheter placement target 6 or more centimeters
Show all 20Show fewer
- Greater than 7 consecutive ribs involved on each side
- Other regional or epidural block already received
- Unable to follow commands/altered mental status
- Dementia
- Sepsis (temperature > 38 degrees Celsius \& positive blood cultures)
- Elevated intracranial pressure (ICP > 12 mm Hg)
- Coagulopathy (INR > 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on)
- Preexisting central nervous system disorders, such as multiple sclerosis
- Thrombocytopenia (Platelets <70,000)
- Spine fracture or previous back surgery
- Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
- Aortic transection
- Hemodynamic instability (patients with MAPs <60 and/or patients requiring pressor support)
- Tattoo at sight of catheter placement
About this study
Official title: Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
Read the detailed description
2.1 Primary Objective
- Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
- Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
- Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
- Compare complications that occur in patients who receive ESPB versus TEA.
- Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
- Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
- Differences in length of stay (LOS) for TEA versus ESPB.
- Differences in risk of delirium between TEA and ESPB.
- Differences in oxygen and ventilatory support between TEA and ESPB.
- Patient satisfaction of pain management.
- Conditions
- Rib Fractures
- Being tested
- ESPB, TEA
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBProcedure or surgery
Ropivacaine is injected near the nerves in the back
TEAProcedure or surgery
Bupivacaine is injected into the space around the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Active comparator | 20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump. Receives: Procedure: ESPB |
| TEA Group | Active comparator | 5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump. Receives: Procedure: TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
Measured: 24 hours after catheter placement
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
Measured: 72 hours after catheter placement
Secondary outcomes (1)
Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.
Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis.
Measured: After patient discharge up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start31 May 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Why it stopped: Study was closed with IRB as PI wants to design the protocol extensively.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Mirman, Indiana University
- Investigators
- Ross Mirman, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069961
- Sponsor's protocol ID
- 11414
- Acronym
- SUETHE-Ribs
- Status last verified
- Oct 2023
- First submitted
- 3 Sep 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Murphy SL, Kochanek KD, Arias E: Mortality in the United States, 2018. In. Edited by Services USDoHaH. Online: National Center for Health Statistics; 2020.
Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
PubMed 7996614Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
PubMed 16269301Bergeron E, Lavoie A, Clas D, Moore L, Ratte S, Tetreault S, Lemaire J, Martin M. Elderly trauma patients with rib fractures are at greater risk of death and pneumonia. J Trauma. 2003 Mar;54(3):478-85. doi: 10.1097/01.TA.0000037095.83469.4C.
PubMed 12634526Shorr RM, Crittenden M, Indeck M, Hartunian SL, Rodriguez A. Blunt thoracic trauma. Analysis of 515 patients. Ann Surg. 1987 Aug;206(2):200-5. doi: 10.1097/00000658-198708000-00013.
PubMed 3606246Moon MR, Luchette FA, Gibson SW, Crews J, Sudarshan G, Hurst JM, Davis K Jr, Johannigman JA, Frame SB, Fischer JE. Prospective, randomized comparison of epidural versus parenteral opioid analgesia in thoracic trauma. Ann Surg. 1999 May;229(5):684-91; discussion 691-2. doi: 10.1097/00000658-199905000-00011.
PubMed 10235527Govindarajan R, Bakalova T, Michael R, Abadir AR. Epidural buprenorphine in management of pain in multiple rib fractures. Acta Anaesthesiol Scand. 2002 Jul;46(6):660-5. doi: 10.1034/j.1399-6576.2002.460605.x.
PubMed 12059888Mackersie RC, Karagianes TG, Hoyt DB, Davis JW. Prospective evaluation of epidural and intravenous administration of fentanyl for pain control and restoration of ventilatory function following multiple rib fractures. J Trauma. 1991 Apr;31(4):443-9; discussion 449-51.
PubMed 1902264Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61.
PubMed 9156291Karmakar MK, Ho AM. Acute pain management of patients with multiple fractured ribs. J Trauma. 2003 Mar;54(3):615-25. doi: 10.1097/01.TA.0000053197.40145.62.
PubMed 12634549Cicala RS, Voeller GR, Fox T, Fabian TC, Kudsk K, Mangiante EC. Epidural analgesia in thoracic trauma: effects of lumbar morphine and thoracic bupivacaine on pulmonary function. Crit Care Med. 1990 Feb;18(2):229-31.
PubMed 2298017Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f.
PubMed 21716105Gabram SG, Schwartz RJ, Jacobs LM, Lawrence D, Murphy MA, Morrow JS, Hopkins JS, Knauft RF. Clinical management of blunt trauma patients with unilateral rib fractures: a randomized trial. World J Surg. 1995 May-Jun;19(3):388-93. doi: 10.1007/BF00299166.
PubMed 7638994Jensen CD, Stark JT, Jacobson LL, Powers JM, Joseph MF, Kinsella-Shaw JM, Denegar CR. Improved Outcomes Associated with the Liberal Use of Thoracic Epidural Analgesia in Patients with Rib Fractures. Pain Med. 2017 Sep 1;18(9):1787-1794. doi: 10.1093/pm/pnw199.
PubMed 27550958De Buck F, Devroe S, Missant C, Van de Velde M. Regional anesthesia outside the operating room: indications and techniques. Curr Opin Anaesthesiol. 2012 Aug;25(4):501-7. doi: 10.1097/ACO.0b013e3283556f58.
PubMed 22673788
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT05069961
- Acronym / sponsor ID
- SUETHE-Ribs / 11414
- Conditions
- Rib Fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was closed with IRB as PI wants to design the protocol extensively.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Oct 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.
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
Detailed description
2.1 Primary Objective
- Compare efficacy of ESPB to TEA for MRF analgesia.
2.2 Secondary Objective
- Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.
2.3 Tertiary/Exploratory/Correlative Objectives
- Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
- Compare complications that occur in patients who receive ESPB versus TEA.
- Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
- Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
- Differences in length of stay (LOS) for TEA versus ESPB.
- Differences in risk of delirium between TEA and ESPB.
- Differences in oxygen and ventilatory support between TEA and ESPB.
- Patient satisfaction of pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Active comparator | Procedure: ESPB20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump. |
| TEA Group | Active comparator | Procedure: TEA5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Radiological evidence of 3 or more rib fractures
- Within 48 hours of admission to hospital with rib fractures
- Can actively participate by answering questions during TEA or ESPB placement
- Moderate-severe (4-10 out of 10) pain at the time of enrollment
Key exclusion criteria (20 listed)
- Greater than 48 hrs since admission to the hospital with rib fractures
- Patient refusal
- Prisoner
- Infection at the site of TEA or ESPB insertion
- Allergy to local anesthetics
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 |
|---|---|---|
| ESPBRopivacaine is injected near the nerves in the back | Procedure or surgery | ESPB Group |
| TEABupivacaine is injected into the space around the spinal cord. | Procedure or surgery | TEA Group |
Primary outcome
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
Time frame: 24 hours after catheter placement
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs.
Time frame: 72 hours after catheter placement
Participants will be asked about their rib pain specifically during this assessment along with the maximum pain experienced and its location. VAS is used to measure pain on a scale of 1-10, with 1 being the least and 10 being the most amount of pain.
1 secondary outcome
Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.
Time frame: After patient discharge up to 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- BackgroundXu J, Murphy SL, Kochanek KD, Arias E: Mortality in the United States, 2018. In. Edited by Services USDoHaH. Online: National Center for Health Statistics; 2020.
- Background: PubMed 7996614Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018.
- Background: PubMed 16269301Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022.
- Background: PubMed 12634526Bergeron E, Lavoie A, Clas D, Moore L, Ratte S, Tetreault S, Lemaire J, Martin M. Elderly trauma patients with rib fractures are at greater risk of death and pneumonia. J Trauma. 2003 Mar;54(3):478-85. doi: 10.1097/01.TA.0000037095.83469.4C.
- Background: PubMed 3606246Shorr RM, Crittenden M, Indeck M, Hartunian SL, Rodriguez A. Blunt thoracic trauma. Analysis of 515 patients. Ann Surg. 1987 Aug;206(2):200-5. doi: 10.1097/00000658-198708000-00013.
- Background: PubMed 10235527Moon MR, Luchette FA, Gibson SW, Crews J, Sudarshan G, Hurst JM, Davis K Jr, Johannigman JA, Frame SB, Fischer JE. Prospective, randomized comparison of epidural versus parenteral opioid analgesia in thoracic trauma. Ann Surg. 1999 May;229(5):684-91; discussion 691-2. doi: 10.1097/00000658-199905000-00011.
- Background: PubMed 12059888Govindarajan R, Bakalova T, Michael R, Abadir AR. Epidural buprenorphine in management of pain in multiple rib fractures. Acta Anaesthesiol Scand. 2002 Jul;46(6):660-5. doi: 10.1034/j.1399-6576.2002.460605.x.
- Background: PubMed 1902264Mackersie RC, Karagianes TG, Hoyt DB, Davis JW. Prospective evaluation of epidural and intravenous administration of fentanyl for pain control and restoration of ventilatory function following multiple rib fractures. J Trauma. 1991 Apr;31(4):443-9; discussion 449-51.
- Background: PubMed 9156291Mayberry JC, Trunkey DD. The fractured rib in chest wall trauma. Chest Surg Clin N Am. 1997 May;7(2):239-61.
- Background: PubMed 12634549Karmakar MK, Ho AM. Acute pain management of patients with multiple fractured ribs. J Trauma. 2003 Mar;54(3):615-25. doi: 10.1097/01.TA.0000053197.40145.62.
- Background: PubMed 2298017Cicala RS, Voeller GR, Fox T, Fabian TC, Kudsk K, Mangiante EC. Epidural analgesia in thoracic trauma: effects of lumbar morphine and thoracic bupivacaine on pulmonary function. Crit Care Med. 1990 Feb;18(2):229-31.
- Background: PubMed 21716105Ho AM, Karmakar MK, Critchley LA. Acute pain management of patients with multiple fractured ribs: a focus on regional techniques. Curr Opin Crit Care. 2011 Aug;17(4):323-7. doi: 10.1097/MCC.0b013e328348bf6f.
- 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.
Ross Mirman, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing ESPB and TEA in people with Rib Fractures, run by Indiana University.
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 20 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: withdrawn, as of the sponsor's last update on 31 Oct 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
MRF pain at rest and with cough before and after TEA or ESPB placement using the pain visual analog scale (VAS) for pain in the thorax/ribs. (time frame: 24 hours after catheter placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069961, which also lists 42 linked publications.
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 31 Oct 2023.