Rib Fractures Clinical Trial
— SUETHE-RibsOfficial title:
Non- Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural Analgesia in Multimodal Pain Management of Multiple Rib Fractures
NCT number | NCT05069961 |
Other study ID # | 11414 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2023 |
Est. completion date | July 31, 2025 |
Verified date | October 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Indiana University |
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incentive spirometry | Maximum incentive spirometry volume (in mL) will be gathered. | Baseline, pre-intervention and immediately following intervention. | |
Other | Rate of adverse events/complications related to ESPB and TEA | 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. | |
Other | Dermatome levels with analgesia | Determine dermatome levels with analgesia using via cold sensory. | Immediately following infusion. | |
Other | Dermatome levels with analgesia | Determine dermatome levels with analgesia using via cold sensory. | 30 minutes after infusion. | |
Other | Dermatome levels with analgesia | 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. | |
Other | Risk assessment profile (RAP) score | 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 | |
Other | The time spent in the intensive care unit (ICU) | Total time spent in ICU | Duration of hospital stay, up to 7 days. | |
Other | Total length of hospital stay | Amount of time each subject spends in the hospital before discharge. | Up to 7 days. | |
Other | Confusion assessment method (CAM-ICU) | 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. | |
Other | Richmond Agitation-Sedation Scale (RASS) | 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. | |
Other | FiO2 and time on a ventilator | 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. | |
Other | Participant satisfaction assessed on a 5 pt. scale | 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. | |
Other | Pain scores | 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. | |
Primary | 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. | 24 hours after catheter placement | |
Primary | 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. | 72 hours after catheter placement | |
Secondary | 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. | After patient discharge up to 7 days |
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