Neuraxial Ultrasound for Thoracic Epidural Placement
Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study
1 other identifier
interventional
70
1 country
1
Brief Summary
This blinded, randomized study compares standard palpation to ultrasound-assisted landmark identification of the thoracic spine for thoracic epidural catheterization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedMay 27, 2016
May 1, 2016
4.8 years
May 18, 2016
May 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to epidural space identification
Needle insertion through the skin until loss-of-resistance with slip syringe, evaluated by a blinded individual reviewing a video recording of the procedure.
Estimated 10 minutes
Secondary Outcomes (4)
Needle passes
Estimated 10 minutes
Needle skin punctures
Estimated 10 minutes
Pain Score
Through study completion, estimated 4 hours
Working epidural
Through study completion, estimated 4 hours
Study Arms (2)
Ultrasound-Assisted
ACTIVE COMPARATORUltrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement
Palpation
ACTIVE COMPARATORPalpation marking of the thoracic spine on the skin for Thoracic Epidural Placement
Interventions
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiology Classification I-IV
- thoracic surgery
- abdominal surgery
You may not qualify if:
- contraindications to epidural catheter
- pregnancy
- coagulopathy
- infection (localized)
- allergy to local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (1)
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.
PMID: 28002229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Auyong, MD
Virginia Mason Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
May 18, 2016
First Posted
May 27, 2016
Study Start
April 1, 2009
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
May 27, 2016
Record last verified: 2016-05