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| ID | Type | Description | Link |
|---|---|---|---|
| No NIH funding | Other Identifier | 12.19.23 |
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The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.
Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.
Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.
Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erector spinae plane block (ESP block) with bupivacaine | Experimental | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle. |
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| ESP block with saline/sham injection | Placebo Comparator | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESP block with bupivacaine | Drug | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Total intravenous (IV) and oral narcotic analgesic use | narcotic use will be measured in morphine milligram equivalents (MME), based on dosing and frequency. | From enrollment/baseline in the study through the study period, up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable) | Baseline (immediately following recruitment). |
| Pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiana Baloescu, MD | Yale University | Principal Investigator |
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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 |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The clinical team taking care of the patient as well as the patient will be blinded as to allocation to experimental or control group. The physician administering the block will also be blinded to the substance administered.
| Saline control/sham injection | Other | Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle. |
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Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable)
| 30 minutes post-baseline |
| Pain score | Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable) | 1 hour post-baseline |
| Pain score | Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable) | 4 hours post-baseline |
| Pain score | Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable) | 12 hours post-baseline |
| Pain score | Pain scores will be measured using a standard11-point numerical rating scale that ranges from 0 ("no pain") to 10 ("worst pain imaginable) | 24 hours post-baseline |
| Hospital length of stay (LOS) | LOS will be identified through the electronic medical record. | From hospital admission to hospital discharge, up to 30 days. |
| Number of Patients Who Develop Pneumonia | Identified through review of the electronic medical record for a discharge diagnosis of pneumonia, or readmission diagnosis of pneumonia within 1 month from presentation. | From admission to 30 days from admission. |
| Adverse events associated with the nerve block itself. | Adverse events will include: hypotension, respiratory depression, and nausea or vomiting. Hypotension will be defined as a systolic blood pressure < 90 mmHg and respiratory depression as respiratory rate < 10 breaths per minute. Nausea or vomiting will be defined as patient-reported sensation of nausea or actual emesis, documented emesis in the medical record, or administration of an antiemetic during the study period. | Within two hours of administration of the nerve block. |
| Total non-narcotic analgesic use. | Non-narcotic analgesic use will be measured by medical record review of all non-narcotic medications. Groups will be compared with respect to each category: non-steroidal anti-inflammatory use, acetaminophen use, local anesthetic patch use. | From enrollment/baseline in the study through the study period, up to 24 hours. |
| D000588 |
| Amines |