Abdominal NeoplasmNCT03890640
Ultrasound-assisted Thoracic Epidural Catheter Insertion
A study testing Ultrasound-guided TECI in people with Abdominal Neoplasm and Thoracic Neoplasm, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Abdominal Neoplasm, Thoracic Neoplasm
- What is being tested?
- Ultrasound-guided TECI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2019to 20 Dec 2019
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo upper abdomen or thoracic surgery
- Scheduled for thoracic epidural catheter insertion
- 20 ≤ age <80
- When obtaining informed consent voluntarily
Who cannot join
- Allergy to local anesthetics and contrast dye, and steroid
- Use of anticoagulants or antiplatelet medication, coagulopathy
- Infection at the insertion site
- Neurological or psychiatric disorders
- Prior spine instrumentation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study
The aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.
Read the detailed description
Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter.
Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.
- Conditions
- Abdominal Neoplasm, Thoracic Neoplasm
- Being tested
- Ultrasound-guided TECI
- Keywords
- Ultrasound, Thoracic epidural catheter insertion, Fluoroscopy
- Medical subject headings
- Abdominal Neoplasms, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided TECIProcedure or surgery
When performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access. All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline. If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided TECI | Experimental | After assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not. Receives: Procedure: Ultrasound-guided TECI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of ultrasound-guided thoracic epidural catheter insertion
Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.
Measured: on the day of the procedure
Secondary outcomes (3)
Number of skin punctures
complete needle withdrawal from the skin and reinsertion at a new location
Measured: on the day of the procedure
Number of needle passes
First needle pass + additional needle passes (the needle returned to a plane perpendicular to the skin before reinsertion. Needle tip maneuvers toward the midline and cephalad were considered standard needle walking technique and were counted as a single pass)
Measured: on the day of the procedure
First attempt success rate
only first needle pass and first skin puncture
Measured: on the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start4 Jul 2019
- Primary completion12 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal NeoplasmStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hyuk Lee, Asan Medical Center
- Investigators
- Jong-Hyuk Lee, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890640
- Sponsor's protocol ID
- 2019-0320
- Status last verified
- Jan 2020
- First submitted
- 25 Mar 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim DH, Lee JH, Sim JH, Jeong W, Lee D, Kwon HM, Choi SS, Jeong SM. Real-time ultrasound-guided low thoracic epidural catheter placement: technical consideration and fluoroscopic evaluation. Reg Anesth Pain Med. 2021 Jun;46(6):512-517. doi: 10.1136/rapm-2021-102578. Epub 2021 Apr 23.
PubMed 33893174
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Real-time Ultrasound-assisted Thoracic Epidural Catheter Insertion: a Pilot Study
- ClinicalTrials.gov ID
- NCT03890640
- Acronym / sponsor ID
- 2019-0320
- Conditions
- Abdominal Neoplasm, Thoracic Neoplasm
- Keywords
- Ultrasound, Thoracic epidural catheter insertion, Fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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 aim of the present study is to access the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy.
Detailed description
Thoracic epidural anesthesia has been associated with reduced acute postoperative pain for a wide variety of surgical procedures. It has also been associated with reductions in perioperative cardiac stress, chronic post-thoracotomy pain, and improvements in postoperative pulmonary function. Although a variety of methods can be used to confirm the position of the epidural needle in the epidural space, a blind technique and fluoroscopic guided approach are a widely used method. A thoracic epidural block is a relatively more difficult procedure than procedures used in other regions, because the spinous process of the thoracic vertebra is longer than that of the lumbar vertebra, and the area through which the needle can approach the epidural space is relatively smaller due to an acute angle and larger distance between the skin and the epidural space. Therefore, the success rate of thoracic epidural intervention is only about 68% under a blind technique due to inadequate position of the needle tip, misplacement, occlusion, and migration of the catheter.
Although fluoroscopic guided thoracic epidural intervention is the safest and most accurate method to identify the correct anatomical structures and confirm the epidural space with contrast medium, its use is limited because of the difficulty of using fluoroscope and the burden of radiation exposure. As the use of ultrasound has become popularized and universal, it has been widely used in regional anesthesia and analgesia, has continuously replaced the modality such as a blind technique and fluoroscopic guidance. Ultrasound-guided thoracic epidural catheter insertion was also recently investigated, and then it was conducted successfully in 15 cases of thoracic and upper abdominal surgery. Moreover, it showed several advantages including lowering the number of needle passes and increasing the success rate. However, it has not yet been studied how accurately the catheter is located in the thoracic epidural space during thoracic epidural catheter insertion using real-time ultrasound. Although it is possible to speculate the success of the thoracic epidural catheterization clinically, the identification of the location of the catheter is only possible under fluoroscopic guidance. Therefore, in the present study, we aimed to confirm the success rate of ultrasound-guided thoracic epidural catheter insertion, using fluoroscopy with contrast medium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided TECI | Experimental | Procedure: Ultrasound-guided TECIAfter assessment of the epidural space using the loss of resistance technique with saline under ultrasound guidance, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo upper abdomen or thoracic surgery
- Scheduled for thoracic epidural catheter insertion
- 20 ≤ age <80
- When obtaining informed consent voluntarily
Key exclusion criteria (6 listed)
- Allergy to local anesthetics and contrast dye, and steroid
- Use of anticoagulants or antiplatelet medication, coagulopathy
- Infection at the insertion site
- Neurological or psychiatric disorders
- Prior spine instrumentation
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-guided TECIWhen performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access. All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline. If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not. | Procedure or surgery | Ultrasound-guided TECI |
Primary outcome
Success rate of ultrasound-guided thoracic epidural catheter insertion
Time frame: on the day of the procedure
Confirmation success of ultrasound-guided thoracic epidural catheter insertion using fluoroscopic images; success means that the catheter tip is located in the epidural space.
3 secondary outcomes
Number of skin punctures
Time frame: on the day of the procedure
Number of needle passes
Time frame: on the day of the procedure
First attempt success rate
Time frame: on the day of the procedure
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 18 Jan 2020.
- Derived from this study: PubMed 33893174Kim DH, Lee JH, Sim JH, Jeong W, Lee D, Kwon HM, Choi SS, Jeong SM. Real-time ultrasound-guided low thoracic epidural catheter placement: technical consideration and fluoroscopic evaluation. Reg Anesth Pain Med. 2021 Jun;46(6):512-517. doi: 10.1136/rapm-2021-102578. Epub 2021 Apr 23.
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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.
Jong-Hyuk Lee, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided TECI in people with Abdominal Neoplasm and Thoracic Neoplasm, run by Asan Medical Center at 1 site in South Korea.
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 4 inclusion and 6 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 18 Jan 2020. 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 South Korea. 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?
Success rate of ultrasound-guided thoracic epidural catheter insertion (time frame: on the day of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890640, which also lists 1 linked publication.
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 18 Jan 2020.