Neuraxial Ultrasound for Thoracic Epidural Placement

Analgesia, Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785055
• Other study ID #: IRB08130
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: May 26, 2016
• Start date: April 2009
• Est. completion date: February 2014

Study information

• Verified date: May 2016
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia, Epidural

Intervention

Procedure:
• Thoracic Epidural Placement
Thoracic Epidural Placement

Drug:
• Bupivacaine 0.05%
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
• Hydromorphone 0.01mg/mL
Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Needle passes	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.	Estimated 10 minutes
Secondary	Needle skin punctures	Complete needle withdrawal from the skin and re-insertion at new location	Estimated 10 minutes
Secondary	Pain Score	Numeric rating scale pain score on recovery room arrival, prior to IV analgesics.	Through study completion, estimated 4 hours
Secondary	Working epidural	Loss of temperature discrimination to ice and pain score <= 5.	Through study completion, estimated 4 hours