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

October 27, 2023 updated by: Ross Mirman, Indiana University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
72 hours after catheter placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Normalize medication use by subtracting baseline opioid and non-opioid medication use for amount received while hospitalized and compare injury severity prior to analysis.
After patient discharge up to 7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incentive spirometry
Time Frame: Baseline, pre-intervention and immediately following intervention.
Maximum incentive spirometry volume (in mL) will be gathered.
Baseline, pre-intervention and immediately following intervention.
Rate of adverse events/complications related to ESPB and TEA
Time Frame: 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.
Duration of hospital stay up to 7 days.
Dermatome levels with analgesia
Time Frame: Immediately following infusion.
Determine dermatome levels with analgesia using via cold sensory.
Immediately following infusion.
Dermatome levels with analgesia
Time Frame: 30 minutes after infusion.
Determine dermatome levels with analgesia using via cold sensory.
30 minutes after infusion.
Dermatome levels with analgesia
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.
Determine dermatome levels with analgesia using via cold sensory.
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.
Risk assessment profile (RAP) score
Time Frame: 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.
After patient discharge up to 7 days
The time spent in the intensive care unit (ICU)
Time Frame: Duration of hospital stay, up to 7 days.
Total time spent in ICU
Duration of hospital stay, up to 7 days.
Total length of hospital stay
Time Frame: Up to 7 days.
Amount of time each subject spends in the hospital before discharge.
Up to 7 days.
Confusion assessment method (CAM-ICU)
Time Frame: 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
Daily during hospital stay up to 7 days.
Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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).
Daily during hospital stay up to 7 days.
FiO2 and time on a ventilator
Time Frame: 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.
Duration of hospital stay, up to 7 days.
Participant satisfaction assessed on a 5 pt. scale
Time Frame: 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".
Daily during hospital stay, up to 7 days.
Pain scores
Time Frame: 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
Duration of hospital stay, up to 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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