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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Procedure: Electrical Nerve stimulation; Drug: Solution For Thoracic epidural block; Procedure: Thoracic epidural block

Study type: Interventional

Funder types: Other

Identifiers

NCT03087604

IRB00039522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Traditional Technique Group

Active Comparator group

Description:

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.

Treatment:

Drug: Solution For Thoracic epidural block

Procedure: Thoracic epidural block

Electric Stimulation Group

Experimental group

Description:

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

Treatment:

Procedure: Electrical Nerve stimulation

Drug: Solution For Thoracic epidural block

Procedure: Thoracic epidural block