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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Technique Group | Active Comparator | 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. |
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| Electric Stimulation Group | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic epidural block | Procedure | Thoracic epidural block with epidural placed with a loss of resistance technique alone. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Dobson, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WakeForestUBMC | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35139802 | Derived | Dobson SW, Weller RS, Edwards C, Turner JD, Jaffe JD, Reynolds JW, Henshaw DS. A randomized comparison of loss of resistance versus loss of resistance plus electrical stimulation: effect on success of thoracic epidural placement. BMC Anesthesiol. 2022 Feb 9;22(1):43. doi: 10.1186/s12871-022-01584-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Technique Group | 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. Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine |
| FG001 | Electric Stimulation Group | 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 Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Electrical Nerve stimulation: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Technique Group | 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. Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 15 minutes after administration of a test dose of lidocaine |
|
up to 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Technique Group | 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. Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Solution For Thoracic epidural block: Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean Dobson | Wake Forest University Health Sciences | 3367168834 | sdobson@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2016 | Oct 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D012996 | Solutions |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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As the patient will be sedated during epidural catheter placement, they will be blinded to their treatment arm. The investigator that determines if the epidural was successful placed will also be blinded to the patient's treatment arm.
| Electrical Nerve stimulation | Procedure | 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. |
|
| Solution For Thoracic epidural block | Drug | Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine |
|
|
the number of thoracic spine levels attempted will be recorded
| Thirty minutes after start of procedure. |
| BG001 | Electric Stimulation Group | 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 Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Electrical Nerve stimulation: 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Electric Stimulation Group | 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 Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Electrical Nerve stimulation: 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 |
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| Secondary | Time Required to Place the Epidural Catheter | The time required to place the epidural catheter will be recorded | Posted | Mean | Standard Deviation | minutes | From the initiation of procedure to end of procedure |
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| Secondary | Number of Thoracic Spine Levels Attempted | the number of thoracic spine levels attempted will be recorded | No data collected | Posted | Thirty minutes after start of procedure. |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Electric Stimulation Group | 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 Thoracic epidural block: Thoracic epidural block with epidural placed with a loss of resistance technique alone. Electrical Nerve stimulation: 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 | 0 | 50 | 0 | 50 | 0 | 50 |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D004364 | Pharmaceutical Preparations |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |