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Completed

NCT Number: NCT03087604

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

WakeForestUBMC

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic epidural block

Procedure

Thoracic epidural block with epidural placed with a loss of resistance technique alone.

Electrical Nerve stimulation

Procedure

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.

Solution For Thoracic epidural block

Drug

Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine

Other names: Lidocaine, Epinephrine

Primary outcomes

  1. 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

  1. Time Required to Place the Epidural Catheter

    Time frame: From the initiation of procedure to end of procedure

    The time required to place the epidural catheter will be recorded

  2. Number of Thoracic Spine Levels Attempted

    Time frame: Thirty minutes after start of procedure.

    the number of thoracic spine levels attempted will be recorded

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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