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

NCT03087604 | Completed Phase 4 Results FDA Device

• 1 other identifier: IRB00039522
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

epidural catheter placement

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes after administration of a test dose of lidocaine

Secondary Outcomes (2)

• Time Required to Place the Epidural Catheter

  From the initiation of procedure to end of procedure

• Number of Thoracic Spine Levels Attempted

  Thirty minutes after start of procedure.

Study Arms (2)

Traditional Technique Group

ACTIVE COMPARATOR

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.

Procedure: Thoracic epidural block; Drug: Solution For Thoracic epidural block

Electric Stimulation Group

EXPERIMENTAL

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

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

Interventions

Thoracic epidural block PROCEDURE

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

Electric Stimulation Group; Traditional Technique Group

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.

Electric Stimulation Group

Solution For Thoracic epidural block DRUG

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

Also known as: Lidocaine, Epinephrine

Electric Stimulation Group; Traditional Technique Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

WakeForestUBMC

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 35139802 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation; Solutions; Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Sean Dobson
• Organization: Wake Forest University Health Sciences

sdobson@wakehealth.edu

3367168834

Study Officials

• Sean Dobson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: As the patient will be sedated during epidural catheter placement, they will be blinded to their treatment arm. The investigator that determines if the epidural was successful placed will also be blinded to the patient's treatment arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 22, 2017
• Study Start: March 17, 2017
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: June 17, 2020
• Results First Posted: November 23, 2018

Record last verified: 2018-10

Locations

US (1)