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

NCT ID: NCT03087604

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2017-10-11

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural block

Intervention Type: PROCEDURE

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

Solution For Thoracic epidural block

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Thoracic epidural block

Intervention Type: PROCEDURE

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

Electrical Nerve stimulation

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Thoracic epidural block

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

Intervention Type: PROCEDURE

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.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.

Intervention Type: PROCEDURE

Solution For Thoracic epidural block

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

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Epinephrine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Dobson, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

WakeForestUBMC

Winston-Salem, North Carolina, United States

Countries

United States

References

Dobson SW, Weller RS, Edwards C, Turner JD, Jaffe JD, Reynolds JW, Henshaw DS. A randomized comparison of loss of resistance versus loss of resistance plus electrical stimulation: effect on success of thoracic epidural placement. BMC Anesthesiol. 2022 Feb 9;22(1):43. doi: 10.1186/s12871-022-01584-x.

Reference Type: DERIVED

PMID: 35139802 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00039522

Identifier Type: -

Identifier Source: org_study_id