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Neuraxial Ultrasound for Thoracic Epidural Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02785055
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
David Auyong, Benaroya Research Institute

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

Condition or disease Intervention/treatment Phase
Analgesia, Epidural Procedure: Thoracic Epidural Placement Drug: Bupivacaine 0.05% Drug: Hydromorphone 0.01mg/mL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study
Study Start Date : April 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785055


Locations
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United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Investigators
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Principal Investigator: David Auyong, MD Virginia Mason Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Auyong, Anesthesiologist, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02785055    
Other Study ID Numbers: IRB08130
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No Plan in place
Additional relevant MeSH terms:
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Hydromorphone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics