Anesthesia
Conditions
Keywords
epidural catheter placement
Brief summary
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
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.
Interventions
PROCEDUREThoracic epidural block
Thoracic epidural block with epidural placed with a loss of resistance technique alone.
PROCEDUREElectrical 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(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.
DRUGSolution For Thoracic epidural block
Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Placement of a Thoracic Epidural | 15 minutes after administration of a test dose of lidocaine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Place the Epidural Catheter | From the initiation of procedure to end of procedure | The time required to place the epidural catheter will be recorded |
| Number of Thoracic Spine Levels Attempted | Thirty minutes after start of procedure. | the number of thoracic spine levels attempted will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Electric Stimulation Group | Total | Traditional Technique Group |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 15.4 | 61.8 years STANDARD_DEVIATION 14.2 | 63.2 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 91 Participants | 45 Participants |
| Sex: Female, Male Female | 27 Participants | 46 Participants | 19 Participants |
| Sex: Female, Male Male | 23 Participants | 54 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 15 minutes after administration of a test dose of lidocaine
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Technique Group | Success Rate of Placement of a Thoracic Epidural | 41 Participants |
| Electric Stimulation Group | Success Rate of Placement of a Thoracic Epidural | 45 Participants |
Secondary
Number of Thoracic Spine Levels Attempted
the number of thoracic spine levels attempted will be recorded
Time frame: Thirty minutes after start of procedure.
Population: No data collected
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Technique Group | Time Required to Place the Epidural Catheter | 33.9 minutes | Standard Deviation 12.8 |
| Electric Stimulation Group | Time Required to Place the Epidural Catheter | 24.0 minutes | Standard Deviation 8 |