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This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.
In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-Assisted | Active Comparator | Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement |
|
| Palpation | Active Comparator | Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Epidural Placement | Procedure | Thoracic Epidural Placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to epidural space identification | Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure. | Estimated 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Needle passes | Attempt to place needle into the interlaminar foramina. Needle tip movements toward midline and cephalad were counted as s single pass. Additional passes were counted when the needle was returned to a plane parallel to the skin. | Estimated 10 minutes |
| Needle skin punctures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Auyong, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28002229 | Derived | Auyong DB, Hostetter L, Yuan SC, Slee AE, Hanson NA. Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):204-209. doi: 10.1097/AAP.0000000000000540. |
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No Plan in place
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2017 | |
| Reset | Mar 16, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2017 | Mar 16, 2017 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Bupivacaine 0.05% | Drug | Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution |
|
| Hydromorphone 0.01mg/mL | Drug | Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution |
|
Complete needle withdrawal from the skin and re-insertion at new location |
| Estimated 10 minutes |
| Pain Score | Numeric rating scale pain score on recovery room arrival, prior to IV analgesics. | Through study completion, estimated 4 hours |
| Working epidural | Loss of temperature discrimination to ice and pain score <= 5. | Through study completion, estimated 4 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |