Post Operative TraumaNCT01172730
The Use of Ultrasound to Measure Depth of Thoracic Epidural Space
An observational study of Post Operative Trauma and Acute Pain, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Trauma, Acute Pain
- What is being tested?
- Ultrasound scanning
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a thoracic epidural catheter for post operative pain
Who may be able to join
- Patients 18 years and older having a thoracic epidural catheter
- Both male and female patients.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique
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
- Being tested
- Ultrasound scanning
- Keywords
- Post operative pain, thoracic epidural, acute pain, Ultrasound scanning of the thoracic spine
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanningDevice
Also called LogicE GE portable ultrasound machine
Ultrasound scanning is used to define needle insertion point and depth of epidural space.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound scanning | Not described Receives: Device: Ultrasound scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of epidural catheter to control pain
Measured: post operative day # 1
Secondary outcomes (1)
The complication rate from epidural catheter placement.
Measured: Immediate complications 24 hrs after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative TraumaStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam Khayata, University of Massachusetts, Worcester
- Investigators
- Issam Khayata, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172730
- Sponsor's protocol ID
- 13495
- Status last verified
- Apr 2013
- First submitted
- 24 May 2010
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound to Measure Depth of Thoracic Epidural Space Compared With Blind Technique
- ClinicalTrials.gov ID
- NCT01172730
- Acronym / sponsor ID
- 13495
- Conditions
- Post Operative Trauma, Acute Pain
- Keywords
- Post operative pain, thoracic epidural, acute pain, Ultrasound scanning of the thoracic spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2013 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound scanning | – | Device: Ultrasound scanning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a thoracic epidural catheter for post operative pain
Key inclusion criteria (2 listed)
- Patients 18 years and older having a thoracic epidural catheter
- Both male and female patients.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanningAlso: LogicE GE portable ultrasound machineUltrasound scanning is used to define needle insertion point and depth of epidural space. | Device | Ultrasound scanning |
Primary outcome
The success rate of epidural catheter to control pain
Time frame: post operative day # 1
1 secondary outcome
The complication rate from epidural catheter placement.
Time frame: Immediate complications 24 hrs after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Khayata, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Trauma and Acute Pain, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of epidural catheter to control pain (time frame: post operative day # 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.