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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03087604
Other study ID # IRB00039522
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 17, 2017
Est. completion date October 11, 2017

Study information

Verified date October 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 11, 2017
Est. primary completion date October 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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(19 Ga. x 90 cm StimuCath® Continuous Nerve Block Catheter with SnapLockā„¢ Adapter (Arrow by Teleflex Medical, Morrisville, NC), and stimulation will be achieved using a B Braun Stimuplex HNS12 Nerve Stimulator product id 4892098.
Drug:
Solution For Thoracic epidural block
Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine

Locations

Country Name City State
United States WakeForestUBMC Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 15 minutes after administration of a test dose of lidocaine
Secondary 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
Secondary Number of Thoracic Spine Levels Attempted the number of thoracic spine levels attempted will be recorded Thirty minutes after start of procedure.
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