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SUETHE-Ribs: Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures

Sponsor
Indiana University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069961
Collaborator
(none)
124
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ESPB
  • Procedure: TEA
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
Anticipated Study Start Date :
Oct 31, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ESPB Group

20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump.

Procedure: ESPB
Ropivacaine is injected near the nerves in the back
Active Comparator: TEA Group

5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump.

Procedure: TEA
Bupivacaine is injected into the space around the spinal cord.

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

  2. 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. [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.

Secondary Outcome Measures

  1. Determine total systemic opioid and non-opioid medication use in patients with ESPB and TEA by reviewing patient EMR. [After patient discharge up to 7 days]

    Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis.

Other Outcome Measures

  1. Incentive spirometry [Baseline, pre-intervention and immediately following intervention.]

    Maximum incentive spirometry volume (in mL) will be gathered.

  2. Rate of adverse events/complications related to ESPB and TEA [Duration of hospital stay up to 7 days.]

    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.

  3. Dermatome levels with analgesia [Immediately following infusion.]

    Determine dermatome levels with analgesia using via cold sensory.

  4. Dermatome levels with analgesia [30 minutes after infusion.]

    Determine dermatome levels with analgesia using via cold sensory.

  5. Dermatome levels with analgesia [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.]

    Determine dermatome levels with analgesia using via cold sensory.

  6. Risk assessment profile (RAP) score [After patient discharge up to 7 days]

    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.

  7. The time spent in the intensive care unit (ICU) [Duration of hospital stay, up to 7 days.]

    Total time spent in ICU

  8. Total length of hospital stay [Up to 7 days.]

    Amount of time each subject spends in the hospital before discharge.

  9. Confusion assessment method (CAM-ICU) [Daily during hospital stay up to 7 days.]

    Scores will be charted daily and reviewed in the EMR to determine if differences in delirium are present for patients receiving TEA versus ESPB

  10. Richmond Agitation-Sedation Scale (RASS) [Daily during hospital stay up to 7 days.]

    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).

  11. FiO2 and time on a ventilator [Duration of hospital stay, up to 7 days.]

    Will be compared between ESPB and TEA. These values are monitored in the EMR and will be reviewed from the EMR.

  12. Participant satisfaction assessed on a 5 pt. scale [Daily during hospital stay, up to 7 days.]

    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".

  13. Pain scores [Duration of hospital stay, up to 7 days.]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: Ross Mirman, MD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ross Mirman, Assistant Professor of Clinical Anesthesia, Indiana University
ClinicalTrials.gov Identifier:
NCT05069961
Other Study ID Numbers:
  • 11414
First Posted:
Oct 6, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures

Study Results

No Results Posted as of Jul 26, 2022