Neuraxial Ultrasound for Thoracic Epidural Placement

May 26, 2016 updated by: David Auyong, Benaroya Research Institute

Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study

This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators will utilize ultrasonography to identify midline bony landmarks including spinous processes, laminae, and intervertebral interspaces prior to the initial needle placement and compare this to standard palpation of the bony thoracic spine for thoracic epidural placement. The investigators will evaluate and compare the two needle localization techniques by the following outcomes: time to identify the epidural space by loss of resistance, needle passes, skin punctures, recovery room pain scores, and epidural success.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiology Classification I-IV
  • thoracic surgery
  • abdominal surgery

Exclusion Criteria:

  • contraindications to epidural catheter
  • pregnancy
  • coagulopathy
  • infection (localized)
  • allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-Assisted
Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement
Procedure: Thoracic Epidural Placement
Thoracic Epidural Placement
Drug: Bupivacaine 0.05%
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Drug: Hydromorphone 0.01mg/mL
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Active Comparator: Palpation
Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement
Procedure: Thoracic Epidural Placement
Thoracic Epidural Placement
Drug: Bupivacaine 0.05%
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Drug: Hydromorphone 0.01mg/mL
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to epidural space identification
Time Frame: Estimated 10 minutes
Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure.
Estimated 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle passes
Time Frame: Estimated 10 minutes
Attempt to place needle into the interlaminar foramina. Needle tip movements toward midline and cephalad were counted as s single pass. Additional passes were counted when the needle was returned to a plane parallel to the skin.
Estimated 10 minutes
Needle skin punctures
Time Frame: Estimated 10 minutes
Complete needle withdrawal from the skin and re-insertion at new location
Estimated 10 minutes
Pain Score
Time Frame: Through study completion, estimated 4 hours
Numeric rating scale pain score on recovery room arrival, prior to IV analgesics.
Through study completion, estimated 4 hours
Working epidural
Time Frame: Through study completion, estimated 4 hours
Loss of temperature discrimination to ice and pain score <= 5.
Through study completion, estimated 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Investigators

  • Principal Investigator: David Auyong, MD, Virginia Mason Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB08130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No Plan in place

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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