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

Wake Forest University Health Sciences100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

100

Conditions

Anesthesia

Interventions

Thoracic epidural blockPROCEDURE

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

Electrical Nerve stimulationPROCEDURE

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 blockDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

WakeForestUBMC

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Number of Thoracic Spine Levels Attempted

the number of thoracic spine levels attempted will be recorded

Time frame: Thirty minutes after start of procedure.

Data from ClinicalTrials.gov

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