Loss of Resistance, w/wo Stimulation, For Epidural Placement

Study Overview
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Brief Summary
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The purpose of this randomized, observer-blinded, investigative trial is to determine if the use of electrical stimulation, compared to the traditional loss of resistance technique alone, improves the success rate of epidural catheter placement at an academic teaching institution.

Detailed Description
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All subjects will receive a thoracic epidural catheter placement at the level appropriate for their surgery and will be randomized to either have the epidural placed with a loss of resistance technique alone or loss of resistance technique with confirmation by nerve stimulation. In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. Nerve stimulation will be started at a pulse width of 0.3 ms and a frequency of 1 Hz and a current of 0.2mA.

Official Title
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Loss of Resistance With Nerve Stimulation Versus Loss of Resistance Alone; Effect on Success of Thoracic Epidural Placement.

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Thoracic epidural block
* Procedure: Electrical Nerve stimulation
* Drug: Solution For Thoracic epidural block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults undergoing intra-thoracic or intra-abdominal procedures that normally would receive thoracic epidurals for post-operative analgesia will be eligible. Exclusion Criteria: Subjects with contraindications to regional anesthesia: history of allergy to amide local anesthetics presence of a progressive neurological deficit patients that are on anticoagulant medications that prohibit placement of an epidural Systemic infection Infection at the site of placement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Technique Group<br>In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block. | Procedure: Thoracic epidural block<br>* Thoracic epidural block with epidural placed with a loss of resistance technique alone.<br>Drug: Solution For Thoracic epidural block<br>* Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine<br>* Other names: Epinephrine;|
| Experimental: Electric Stimulation Group<br>In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. After placement of the catheter a standard test dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine will be administered.Solution for Thoracic epidural block.Thoracic epidural block with Electrical Nerve stimulation | Procedure: Thoracic epidural block<br>* Thoracic epidural block with epidural placed with a loss of resistance technique alone.<br>Procedure: Electrical Nerve stimulation<br>* In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters(19 Ga. x 90 cm StimuCath® Continuous Nerve Block Catheter with SnapLock™ Adapter (Arrow by Teleflex Medical, Morrisville, NC), and stimulation will be achieved using a B Braun Stimuplex HNS12 Nerve Stimulator product id 4892098.<br>Drug: Solution For Thoracic epidural block<br>* Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine<br>* Other names: Epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Placement of a Thoracic Epidural | will be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful. | 15 minutes after administration of a test dose of lidocaine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Required to Place the Epidural Catheter | The time required to place the epidural catheter will be recorded | From the initiation of procedure to end of procedure | 
| Number of Thoracic Spine Levels Attempted | the number of thoracic spine levels attempted will be recorded | Thirty minutes after start of procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural catheter placement