NCT03559023

Brief Summary

To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle trajectory. The use of sterile manometry tubing to demonstrate a falling and oscillating fluid column has been described as a confirmatory test in the placement of lumbar epidurals. This study will determine if the efficacy of thoracic epidural placement is improved if placement is performed with the use of either US, or manometry, or both techniques combined, compared with a standard landmark-based placement technique alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

June 5, 2018

Last Update Submit

March 2, 2020

Conditions

Surgery

Keywords

Thoracic epidural

Outcome Measures

Primary Outcomes (1)

  • Successful thoracic epidural placement

    Successful thoracic epidural placement as measured by diminished sensation to pinprick in two or more adjacent dermatomes 15 minutes after the injection of 5 mL of 1.5% lidocaine with 1:200,000 epinephrine into an epidural catheter.

    15 minutes after injection of 1.5% lidocaine

Secondary Outcomes (5)

  • Diminished sensation to cold

    15 minutes after injection of lidocaine

  • Average pain score

    First 24 hours postoperatively

  • Number of attempts

    During epidural placement

  • Procedure time

    During epidural placement

  • Complications

    During epidural placement

Study Arms (4)

Ultrasound Only

ACTIVE COMPARATOR

Ultrasound assisted epidural placement

Procedure: Ultrasound Only

Manometry Only

ACTIVE COMPARATOR

Manometry confirmation in epidural placement

Procedure: Manometry Only

Ultrasound Plus Manometry

ACTIVE COMPARATOR

Ultrasound Plus Manometry confirmation in epidural placement

Procedure: Ultrasound Plus Manometry

Usual Care/Management

SHAM COMPARATOR

Usual epidural technique placement

Procedure: Usual Care/Management

Interventions

Ultrasound OnlyPROCEDURE

The anesthesia team will use ultrasound to scan on subject's upper back (thoracic spine) to identify a place to begin the epidural procedure. A pen will be used to place markings on subject's back.

Ultrasound Only
Manometry OnlyPROCEDURE

The anesthesia team will use an extra piece of tubing to confirm the epidural space one the epidural space is established.

Manometry Only
Ultrasound Plus ManometryPROCEDURE

The anesthesia team will use both ultrasound and manometry to assist with epidural placement.

Ultrasound Plus Manometry
Usual Care/ManagementPROCEDURE

The epidural will be placed using the usual technique utilized by the anesthesiology department. The the usual care/management group will receive a sham ("fake") ultrasound exam of subject's upper back with fake pen markings placed on subject's back. The ultrasound machine will not be turned on.

Usual Care/Management

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epidural indicated for a T4-T10 placement site
  • American Society of Anesthesiologists (ASA) physical status I to IV

You may not qualify if:

  • Non-English speaking subjects in situations when an interpreter or consent in their native language is not available.
  • Pregnant women
  • Decsionally impaired
  • Prisoners
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Interventions

High-Energy Shock WavesManometry

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaInvestigative Techniques

Study Officials

  • Ryan Ivie, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Ivie, MD

CONTACT

503-494-7641ivie@ohsu.edu

Laura Sissons-Ross

CONTACT

503-494-7328sissonsr@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 15, 2018

Study Start

June 12, 2018

Primary Completion

August 30, 2020

Study Completion

September 30, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations

US(1)