Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Study Overview
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Brief Summary
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Various modalities have been proposed for real-time confirmation of loss of resistance (LOR) for thoracic epidural blocks. With real-time ultrasound (US) guidance, the anesthesiologist attempts to visualize the sonographic advancement of the epidural needle and penetration of the epidural space (as detected by LOR) This observational study is set out to confirm the reliability of real-time ultrasound guidance as an adjunct to LOR for thoracic epidural blocks.

Official Title
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Reliability of Real-time Ultrasound Guidance as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks

Conditions
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Analgesia, Thoracic Tumors, Abdomen Tumors, Rib Fractures

Intervention / Treatment
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* Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years American Society of Anesthesiologists classification 1-3 Body mass index between 20 and 35 (kg/m2) Exclusion Criteria: Adults who are unable to give their own consent Sepsis (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. leukocytosis, increased c-reactive protein, increased procalcitonin) Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50) Allergy to local anesthetics (LAs) Prior surgery in the thoracic spine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures<br>Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures who will have placed a thoracic epidural catheter to manage their perioperative analgesia. | Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.<br>* With an US-guided parasagittal oblique approach, the interlaminar space at the union between laminas and spinous processes at the predefined insertion level will be identified. A skin wheal will be raised with 3 mL of lidocaine 1%. Afterward, an 18-gauge Tuohy epidural block needle will be advanced under direct US vision until the tip is insinuated between the laminas and anchored to the flavum ligament. Then the needle will be attached to a low resistance syringe prefilled with saline solution and advanced until LOR to injection is confirmed. Then a 20-Gauge epidural catheter will be inserted 3-5 cm beyond the needle tip inside the epidural space and the needle removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful epidural blocks after US-guided insertion of epidural catheters | After fifteen minutes of local anesthetic administration (4- mL dose of lidocaine 2% with epinephrine 5 μg/mL ), an investigator will apply ice to the T1 to L4 dermatomes bilaterally. The criterion standard for success will be the presence of an epidural block, defined as a block to ice in at least 2 dermatomes bilaterally. If operators could not advance the catheter past the needle tip after 2 attempts despite a 180-degree rotation of the bevel between the first and second attempts, epidural blocks will be considered failures. | 15 minutes after the local anesthetic injection through the epidural catheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blocked dermatomes | Number of blocked dermatomes after injection of local anesthetics through the epidural catheter. | 15 minutes after the local anesthetic injection through the epidural catheter | 
| Localization of blocked dermatomes | Localization of blocked dermatomes after injection of local anesthetics through the epidural catheter. | 15 minutes after the local anesthetic injection through the epidural catheter | 
| Image time | Needed time (minutes and seconds) to obtain an adequate image of the interlaminar space | Up to 30 minutes after skin disinfection | 
| Needle time | Needed time (minutes and seconds) to insert the Tuohy needle tip in the interlaminar space and confirm a loss of resistance | Up to 30 minutes after skin disinfection | 
| Catheter installation time | Elapsed time (minutes and seconds) from loss of resistance acquisition until the catheter is secured | Up to 30 minutes after skin disinfection | 
| Block performance time | Time (minutes and seconds) between skin disinfection and once the catheter is secured in place. | Up to 30 minutes after skin disinfection | 
| Epidural block-related complications | Incidence of adverse events related to epidural block or local anesthetic injection (i.e. paresthesia, accidental dural puncture, intravascular or subarachnoid position of catheters, intravascular, subarachnoid or subdural injection, local anesthetic systemic toxicity) | Up to 30 minutes after skin disinfection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic peridural, Ultrasound-guided