A Phase 4 interventional study of Thoracic epidural block and Electrical Nerve stimulation in Anesthesia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Supportive care
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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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 · Drug: Solution For Thoracic epidural block
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 · Procedure: Electrical Nerve stimulation · Drug: Solution For Thoracic epidural block
Thoracic epidural block with epidural placed with a loss of resistance technique alone.
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.
Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
Also known as: Lidocaine, Epinephrine
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.
Time frame: 15 minutes after administration of a test dose of lidocaine
Time Required to Place the Epidural Catheter
The time required to place the epidural catheter will be recorded
Time frame: 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
Time frame: Thirty minutes after start of procedure.
| Milestone | Traditional Technique Group | Electric Stimulation Group |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
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.
| Participants | Traditional Technique Group | Electric Stimulation Group |
|---|---|---|
| Success Rate of Placement of a Thoracic Epidural | 41 | 45 |
The time required to place the epidural catheter will be recorded
| minutes | Traditional Technique Group | Electric Stimulation Group |
|---|---|---|
| Time Required to Place the Epidural Catheter | 33.9 ± 12.8 | 24.0 ± 8.0 |
the number of thoracic spine levels attempted will be recorded
No measurements were reported for this outcome.
Collected over up to 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traditional Technique Group | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Electric Stimulation Group | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Traditional Technique Group | Electric Stimulation Group | Total |
|---|---|---|---|
| Mean | 63.2 ± 12.6 | 60.4 ± 15.4 | 61.8 ± 14.2 |
| Sex: Female, Male(Participants) | Traditional Technique Group | Electric Stimulation Group | Total |
|---|---|---|---|
| Female | 19 | 27 | 46 |
| Male | 31 | 23 | 54 |
| Race (NIH/OMB)(Participants) | Traditional Technique Group | Electric Stimulation Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 45 | 46 | 91 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Wake Forest University Health Sciences