The Use of Ultrasound to Measure Depth of Thoracic Epidural Space

NCT01172730 | Completed

• 1 other identifier: 13495
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique. The study hypothesis is the use of Ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.

Conditions

Post Operative Trauma; Acute Pain

Keywords

Post operative pain; thoracic epidural; acute pain; Ultrasound scanning of the thoracic spine

Outcome Measures

Primary Outcomes (1)

• The success rate of epidural catheter to control pain

  post operative day # 1

Secondary Outcomes (1)

• The complication rate from epidural catheter placement.

  Immediate complications 24 hrs after

Study Arms (1)

Ultrasound scanning

Device: Ultrasound scanning

Interventions

Ultrasound scanning DEVICE

Ultrasound scanning is used to define needle insertion point and depth of epidural space.

Also known as: LogicE GE portable ultrasound machine

Ultrasound scanning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having a thoracic epidural catheter for post operative pain

You may qualify if:

• Patients 18 years and older having a thoracic epidural catheter
• Both male and female patients.

You may not qualify if:

• Pediatric population \< 18 years of age
• Pregnancy
• Prisoners
• Absolute Contraindication to thoracic epidural placement severe scoliosis or deformity,
• Patients with previous spine surgery or hardware implanted at level of epidural placement,
• Anticipated ventilation postoperatively for a period more that 24 hrs
• Lack of patient consent to enroll in the study

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Issam Khayata, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principle Investigator

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: July 30, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2013
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

US (1)