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Study was closed with IRB as PI wants to design the protocol extensively.
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The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.
2.1 Primary Objective
2.2 Secondary Objective
2.3 Tertiary/Exploratory/Correlative Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESPB Group | Active Comparator | 20ml Ropivacaine is injected near the nerves in the back and then continued using an infusion pump. |
|
| TEA Group | Active Comparator | 5ml Bupivacaine is injected into the space around the spinal cord and then continued using an infusion pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESPB | Procedure | Ropivacaine is injected near the nerves in the back |
| |
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incentive spirometry | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross Mirman, MD | Indiana University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 7996614 | Background | 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. | |
| 16269301 |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| TEA |
| Procedure |
Bupivacaine is injected into the space around the spinal cord. |
|
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 | Determine dermatome levels with analgesia using via cold sensory. | Immediately following infusion. |
| Dermatome levels with analgesia | Determine dermatome levels with analgesia using via cold sensory. | 30 minutes after infusion. |
| 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. |
| 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 |
| The time spent in the intensive care unit (ICU) | Total time spent in ICU | Duration of hospital stay, up to 7 days. |
| Total length of hospital stay | Amount of time each subject spends in the hospital before discharge. | Up to 7 days. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Background |
| Flagel 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. |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |