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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087604
• Other study ID #: IRB00039522
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia

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 SnapLock™ 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.