Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures (SUETHE-Ribs)
Primary Purpose
Rib Fractures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESPB
TEA
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESPB Group
TEA Group
Arm Description
20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.
5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05069961
Brief Title
Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
Acronym
SUETHE-Ribs
Official Title
Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESPB Group
Arm Type
Active Comparator
Arm Description
20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.
Arm Title
TEA Group
Arm Type
Active Comparator
Arm Description
5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.
Intervention Type
Procedure
Intervention Name(s)
ESPB
Intervention Description
Ropivacaine is injected near the nerves in the back
Intervention Type
Procedure
Intervention Name(s)
TEA
Intervention Description
Bupivacaine is injected into the space around the spinal cord.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 hours after catheter placement
Title
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.
Description
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.
Time Frame
72 hours after catheter placement
Secondary Outcome Measure Information:
Title
Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR.
Description
Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis.
Time Frame
After patient discharge up to 7 days
Other Pre-specified Outcome Measures:
Title
Incentive spirometry
Description
Maximum incentive spirometry volume (in mL) will be gathered.
Time Frame
Baseline, pre-intervention and immediately following intervention.
Title
Rate of adverse events/complications related to ESPB and TEA
Description
Track adverse events/complications related to ESPB and TEA such as pneumothorax, pneumonia, infection at catheter site, DVT, pulmonary embolism, urinary retention, hypotension, spinal cord injury, systemic anesthetic toxicity, epidural hematoma, and loss of motor function.
Time Frame
Duration of hospital stay up to 7 days.
Title
Dermatome levels with analgesia
Description
Determine dermatome levels with analgesia using via cold sensory.
Time Frame
Immediately following infusion.
Title
Dermatome levels with analgesia
Description
Determine dermatome levels with analgesia using via cold sensory.
Time Frame
30 minutes after infusion.
Title
Dermatome levels with analgesia
Description
Determine dermatome levels with analgesia using via cold sensory.
Time Frame
Once a day in the morning, after intervention. They will be checked until the catheter is removed, which will be 7 days at the longest.
Title
Risk assessment profile (RAP) score
Description
Standard trauma protocol includes all trauma inpatients getting a risk assessment profile (RAP) score. A RAP score <5 needs no additional monitoring. A RAP score >/= 5 gets anti-Xa monitoring (4 hrs after 3rd consecutive dose with goal parameters 0.2-0.4). A RAP score >/= 11 gets Anti-Xa monitoring plus weekly lower extremity dopplers ultrasound. This data will be in the EMR as it is standard protocol currently.
Time Frame
After patient discharge up to 7 days
Title
The time spent in the intensive care unit (ICU)
Description
Total time spent in ICU
Time Frame
Duration of hospital stay, up to 7 days.
Title
Total length of hospital stay
Description
Amount of time each subject spends in the hospital before discharge.
Time Frame
Up to 7 days.
Title
Confusion assessment method (CAM-ICU)
Description
Scores will be charted daily and reviewed in the EMR to determine if differences in delirium are present for patients receiving TEA versus ESPB
Time Frame
Daily during hospital stay up to 7 days.
Title
Richmond Agitation-Sedation Scale (RASS)
Description
Scores will be charted daily and reviewed in the EMR to determine if differences in sedation are present for patients receiving TEA versus ESPB. The scale ratings range from +4 (combative/violent/immediate danger) to -5 (unarousable).
Time Frame
Daily during hospital stay up to 7 days.
Title
FiO2 and time on a ventilator
Description
Will be compared between ESPB and TEA. These values are monitored in the EMR and will be reviewed from the EMR.
Time Frame
Duration of hospital stay, up to 7 days.
Title
Participant satisfaction assessed on a 5 pt. scale
Description
Assess participant satisfaction of the ESPB and TEA for MRF pain management on a 5 pt scale with 0 being "unsatisfied" and 4 being "very satisfied".
Time Frame
Daily during hospital stay, up to 7 days.
Title
Pain scores
Description
Pain scores are tracked in the EMR at multiple times during the day. These will be utilized to compare morning and evening charted pain scores to the ones obtained during the morning data collection
Time Frame
Duration of hospital stay, up to 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ross Mirman, MD
Phone
(317) 274-0275
Email
rmirman@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lyla Farlow, LPN
Phone
317-948-9804
Email
lychrist@iupui.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Mirman, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures
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