Neuraxial Ultrasound for Thoracic Epidural Placement

Study Overview
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Brief Summary
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This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.

Detailed Description
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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.

Official Title
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Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study

Conditions
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Analgesia, Epidural

Intervention / Treatment
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* Procedure: Thoracic Epidural Placement
* Drug: Bupivacaine 0.05%
* Drug: Hydromorphone 0.01mg/mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology Classification I-IV thoracic surgery abdominal surgery Exclusion Criteria: contraindications to epidural catheter pregnancy coagulopathy infection (localized) allergy to local anesthetics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-Assisted<br>Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement | Procedure: Thoracic Epidural Placement<br>* Thoracic Epidural Placement<br>Drug: Bupivacaine 0.05%<br>* Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution<br>Drug: Hydromorphone 0.01mg/mL<br>* Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution<br>|
| Active Comparator: Palpation<br>Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement | Procedure: Thoracic Epidural Placement<br>* Thoracic Epidural Placement<br>Drug: Bupivacaine 0.05%<br>* Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution<br>Drug: Hydromorphone 0.01mg/mL<br>* Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |