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Completed

NCT Number: NCT02785055

Neuraxial Ultrasound for Thoracic Epidural Placement

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

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Key information

Conditions

Analgesia, Epidural Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic Epidural Placement

Procedure

Thoracic Epidural Placement

Bupivacaine 0.05%

Drug

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

Hydromorphone 0.01mg/mL

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Needle skin punctures

    Time frame: Estimated 10 minutes

    Complete needle withdrawal from the skin and re-insertion at new location

  3. Pain Score

    Time frame: Through study completion, estimated 4 hours

    Numeric rating scale pain score on recovery room arrival, prior to IV analgesics.

  4. Working epidural

    Time frame: Through study completion, estimated 4 hours

    Loss of temperature discrimination to ice and pain score <= 5.

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 27, 2016
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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