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Neuraxial Ultrasound for Thoracic Epidural Placement

NCT ID: NCT02785055

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Analgesia, Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasound-Assisted

Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Placement

Intervention Type PROCEDURE

Thoracic Epidural Placement

Bupivacaine 0.05%

Intervention Type DRUG

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Hydromorphone 0.01mg/mL

Intervention Type DRUG

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Palpation

Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Placement

Intervention Type PROCEDURE

Thoracic Epidural Placement

Bupivacaine 0.05%

Intervention Type DRUG

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Hydromorphone 0.01mg/mL

Intervention Type DRUG

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Interventions

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Thoracic Epidural Placement

Thoracic Epidural Placement

Intervention Type PROCEDURE

Bupivacaine 0.05%

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Intervention Type DRUG

Hydromorphone 0.01mg/mL

Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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David Auyong

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Auyong, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Auyong DB, Hostetter L, Yuan SC, Slee AE, Hanson NA. Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):204-209. doi: 10.1097/AAP.0000000000000540.

Reference Type DERIVED
PMID: 28002229 (View on PubMed)

Other Identifiers

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IRB08130

Identifier Type: -

Identifier Source: org_study_id

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