The Use of Ultrasound to Measure Depth of Thoracic Epidural Space
This study has been completed.
Information provided by (Responsible Party):
Issam Khayata, University of Massachusetts, Worcester
First received: May 24, 2010
Last updated: April 9, 2013
Last verified: April 2013
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.
Post Operative Trauma
Device: Ultrasound scanning
||Observational Model: Case-Only
Time Perspective: Prospective
||Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique
Primary Outcome Measures:
- The success rate of epidural catheter to control pain [ Time Frame: post operative day # 1 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The complication rate from epidural catheter placement. [ Time Frame: Immediate complications 24 hrs after ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Device: Ultrasound scanning
Ultrasound scanning is used to define needle insertion point and depth of epidural space.
Other Name: LogicE GE portable ultrasound machine
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients having a thoracic epidural catheter for post operative pain
- Patients 18 years and older having a thoracic epidural catheter
- Both male and female patients.
- Pediatric population < 18 years of age
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172730
|UMass Memorial Medical Center
|Worcester, Massachusetts, United States, 01655 |
University of Massachusetts, Worcester
||Issam Khayata, MD
||University of Massachusetts, Worcester
No publications provided
||Issam Khayata, Study Principle Investigator, University of Massachusetts, Worcester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 24, 2010
||April 9, 2013
||United States: Institutional Review Board
Keywords provided by University of Massachusetts, Worcester:
Post operative pain
Ultrasound scanning of the thoracic spine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Nervous System Diseases
Signs and Symptoms