Recruiting

Ultrasound & Manometry

Sponsor:

Oregon Health and Science University

Code:

NCT03559023

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound Only

Manometry Only

Ultrasound Plus Manometry

Usual Care/Management

Study Details

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.

Conditions

Surgery

Study ID

NCT03559023

Start date

Jun 12, 2018

Status verified date

Mar, 2020

Completion date

Sep 30, 2020

Anticipated

Primary completion date

Aug 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Ultrasound Only

Ultrasound assisted epidural placement

active comparator: Manometry Only

Manometry confirmation in epidural placement

active comparator: Ultrasound Plus Manometry

Ultrasound Plus Manometry confirmation in epidural placement

sham comparator: Usual Care/Management

Usual epidural technique placement

Interventions

Ultrasound Only

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.

Manometry Only

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

Ultrasound Plus Manometry

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

Usual Care/Management

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.

Primary outcome measure

  • Successful thoracic epidural placement [ Time Frame: 15 minutes after injection of 1.5% lidocaine ]

Central Contacts and Locations

Central contacts

Ryan Ivie, MD

503-494-7641ivie@ohsu.edu

Laura Sissons-Ross

503-494-7328sissonsr@ohsu.edu

Locations

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ryan Ivie, MD

503-494-7641ivie@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Mar 3, 2020

Last verified

Mar, 2020

Keywords

  • Thoracic epidural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2020-03-03.