Patients Undergoing Thoracic SurgeryNCT01764932
Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
A study testing Fluoroscopic imaging in people with Patients Undergoing Thoracic Surgery and Patients Undergoing Upper Abdominal Surgery, run by Chicago Anesthesia Pain Specialists at 1 site in United States.
Trial summary
In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Undergoing Thoracic Surgery, Patients Undergoing Upper Abdominal Surgery
- What is being tested?
- Fluoroscopic imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 80 years old patients
- Patients undergoing thoracic surgery
- Patients undergoing upper abdominal surgery
Who cannot join
- Severe Aortic Valve stenosis
- Active Neurologic Disease
- Allergy to lidocaine or bupivacaine
- Allergy to iodine-based contrast
- Cutaneous Disorders at epidural insertion site
- Preoperative impaired coagulation status
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
About this study
Official title: Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.
Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.
Read the detailed description
Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.
Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.
- Being tested
- Fluoroscopic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopic imagingProcedure or surgery
Contrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural catheter insertion | Other | Fluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery Receives: Procedure: Fluoroscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presumed intervertebral level of epidural catheter
At the time of thoracic epidural catheter insertion
Measured: During procedure
Secondary outcomes (2)
Radiologic confirmation of epidural catheter placement
Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.
Measured: Post procedure within one week.
Change in Numeric Rating Pain Score from baseline
1, 24, and 48 hrs after the end of the surgery.
Measured: 1, 24 and 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startDec 2011
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chicago Anesthesia Pain Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth D Candido, Chicago Anesthesia Pain Specialists
- Investigators
- Kenneth D Candido, M.D., Principal investigator, Chicago Anesthesia Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764932
- Sponsor's protocol ID
- Advocate-IRB-5242
- Status last verified
- Sep 2017
- First submitted
- 2 Jan 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
- ClinicalTrials.gov ID
- NCT01764932
- Acronym / sponsor ID
- Advocate-IRB-5242
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chicago Anesthesia Pain SpecialistsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Jan 2013 (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.
In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.
Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.
Detailed description
Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.
Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural catheter insertion | Other | Procedure: Fluoroscopic imagingFluoroscopic imaging. For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18- 80 years old patients
- Patients undergoing thoracic surgery
- Patients undergoing upper abdominal surgery
Key exclusion criteria (7 listed)
- Severe Aortic Valve stenosis
- Active Neurologic Disease
- Allergy to lidocaine or bupivacaine
- Allergy to iodine-based contrast
- Cutaneous Disorders at epidural insertion site
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 |
|---|---|---|
| Fluoroscopic imagingContrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections. | Procedure or surgery | Thoracic epidural catheter insertion |
Primary outcome
Presumed intervertebral level of epidural catheter
Time frame: During procedure
At the time of thoracic epidural catheter insertion
2 secondary outcomes
Radiologic confirmation of epidural catheter placement
Time frame: Post procedure within one week.
Change in Numeric Rating Pain Score from baseline
Time frame: 1, 24 and 48 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
Kenneth D Candido, M.D. principal investigator
Chicago Anesthesia Pain Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopic imaging in people with Patients Undergoing Thoracic Surgery and Patients Undergoing Upper Abdominal Surgery, run by Chicago Anesthesia Pain Specialists 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 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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?
Results are not available in the source record.
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?
Presumed intervertebral level of epidural catheter (time frame: During procedure). 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 14 Sep 2017.