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Clinical Trials/NCT03087604
NCT03087604
Completed
Phase 4

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

Wake Forest University Health Sciences1 site in 1 country100 target enrollmentMarch 17, 2017

Overview

Phase
Phase 4
Intervention
Thoracic epidural block
Conditions
Anesthesia
Sponsor
Wake Forest University Health Sciences
Enrollment
100
Locations
1
Primary Endpoint
Success Rate of Placement of a Thoracic Epidural
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 17, 2017
End Date
October 11, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Thoracic epidural block

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.

Intervention: Solution For Thoracic epidural block

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

Intervention: Thoracic epidural block

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

Intervention: Electrical Nerve stimulation

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

Intervention: Solution For Thoracic epidural block

Outcomes

Primary Outcomes

Success Rate of Placement of a Thoracic Epidural

Time Frame: 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 Outcomes

  • Time Required to Place the Epidural Catheter(From the initiation of procedure to end of procedure)
  • Number of Thoracic Spine Levels Attempted(Thirty minutes after start of procedure.)

Study Sites (1)

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