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

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Thoracic epidural block; Drug: Solution For Thoracic epidural block; Procedure: Electrical Nerve stimulation

• Registration Number: NCT03087604
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-16
• Study Start: 2017-03-17
• Study First Posted: 2017-03-22
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Status Verified: 2018-10
• Results First Submitted: 2018-10-24
• Results First Submitted QC: 2018-10-24
• Results First Posted: 2018-11-23
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults undergoing intra-thoracic or intra-abdominal procedures that normally would receive thoracic epidurals for post-operative analgesia will be eligible.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Technique Group	Thoracic epidural block	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.
Traditional Technique Group	Solution For Thoracic epidural block	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.
Electric Stimulation Group	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. 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
Electric Stimulation Group	Solution For Thoracic epidural block	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
Electric Stimulation Group	Thoracic epidural block	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

Primary Outcome Measures

Name	Time	Method
Success Rate of Placement of a Thoracic Epidural	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 Outcome Measures

Name	Time	Method
Time Required to Place the Epidural Catheter	From the initiation of procedure to end of procedure	The time required to place the epidural catheter will be recorded
Number of Thoracic Spine Levels Attempted	Thirty minutes after start of procedure.	the number of thoracic spine levels attempted will be recorded

Trial Locations

Locations (1)

WakeForestUBMC; 🇺🇸 Winston-Salem, North Carolina, United States