Neuraxial Ultrasound for Thoracic Epidural Placement

Not Applicable

Completed

• Conditions: Analgesia, Epidural
• Interventions: Procedure: Thoracic Epidural Placement; Drug: Bupivacaine 0.05%; Drug: Hydromorphone 0.01mg/mL

• Registration Number: NCT02785055
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-26
• Last Update Submitted: 2016-05-26
• Study First Posted: 2016-05-27
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palpation	Hydromorphone 0.01mg/mL	Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement
Ultrasound-Assisted	Hydromorphone 0.01mg/mL	Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement
Ultrasound-Assisted	Bupivacaine 0.05%	Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement
Ultrasound-Assisted	Thoracic Epidural Placement	Ultrasound assisted marking of the thoracic spine on the skin for Thoracic Epidural Placement
Palpation	Thoracic Epidural Placement	Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement
Palpation	Bupivacaine 0.05%	Palpation marking of the thoracic spine on the skin for Thoracic Epidural Placement

Primary Outcome Measures

Name	Time	Method
Time to epidural space identification	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

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

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States