Regional Anesthesia MorbidityNCT04001387
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning
An observational study of Regional Anesthesia Morbidity, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Real-time ultrasound guided spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2019to 26 Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who scheduled for elective surgery under spinal anesthesia
Who may be able to join
- Patients who scheduled for elective surgery under spinal anesthesia
- Age >= 20
Who cannot join
- Patient refusal
- Coagulopathy (INR ≥1.2, anticoagulant therapy)
- Sepsis or local infection at the site of injection
- BMI > 35
- Spine deformity
Trial locations and contacts
1 site in 1 country.
About this study
Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug.
In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Real-time ultrasound guided spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time ultrasound guided spinal anesthesiaProcedure or surgery
The neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Not described Receives: Procedure: Real-time ultrasound guided spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful perfomance of spinal anesthesia
Rate of successful performance of real-time ultrasound guided spinal needle insertion using dynamic needle tip positioning
Measured: Assessed at time of spinal anesthetic injection (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start27 Oct 2019 (estimated)
- Primary completion26 May 2020 (estimated)
- Study completion26 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001387
- Sponsor's protocol ID
- 20-2019-32
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
PubMed 11172514Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.
PubMed 17350519Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
PubMed 18319185Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
PubMed 14768920Hanada S, Van Winkle MT, Subramani S, Ueda K. Dynamic ultrasound-guided short-axis needle tip navigation technique vs. landmark technique for difficult saphenous vein access in children: a randomised study. Anaesthesia. 2017 Dec;72(12):1508-1515. doi: 10.1111/anae.14082. Epub 2017 Oct 6.
PubMed 28983903Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.
PubMed 29135593Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
PubMed 29787409Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.
PubMed 30638922
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning
- ClinicalTrials.gov ID
- NCT04001387
- Acronym / sponsor ID
- 20-2019-32
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2019 (estimated)
- Primary completion
- 26 May 2020 (estimated)
- Study completion
- 26 Jun 2020 (estimated)
- First posted
- 28 Jun 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.
Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug.
In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | – | Procedure: Real-time ultrasound guided spinal anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who scheduled for elective surgery under spinal anesthesia
Key inclusion criteria (2 listed)
- Patients who scheduled for elective surgery under spinal anesthesia
- Age >= 20
Key exclusion criteria (5 listed)
- Patient refusal
- Coagulopathy (INR ≥1.2, anticoagulant therapy)
- Sepsis or local infection at the site of injection
- BMI > 35
- Spine deformity
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 |
|---|---|---|
| Real-time ultrasound guided spinal anesthesiaThe neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic. | Procedure or surgery | Spinal anesthesia |
Primary outcome
Successful perfomance of spinal anesthesia
Time frame: Assessed at time of spinal anesthetic injection (baseline)
Rate of successful performance of real-time ultrasound guided spinal needle insertion using dynamic needle tip positioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Background: PubMed 11172514Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
- Background: PubMed 17350519Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.
- Background: PubMed 18319185Carvalho JC. Ultrasound-facilitated epidurals and spinals in obstetrics. Anesthesiol Clin. 2008 Mar;26(1):145-58, vii-viii. doi: 10.1016/j.anclin.2007.11.007.
- Background: PubMed 14768920Grau T, Leipold RW, Fatehi S, Martin E, Motsch J. Real-time ultrasonic observation of combined spinal-epidural anaesthesia. Eur J Anaesthesiol. 2004 Jan;21(1):25-31. doi: 10.1017/s026502150400105x.
- Background: PubMed 28983903Hanada S, Van Winkle MT, Subramani S, Ueda K. Dynamic ultrasound-guided short-axis needle tip navigation technique vs. landmark technique for difficult saphenous vein access in children: a randomised study. Anaesthesia. 2017 Dec;72(12):1508-1515. doi: 10.1111/anae.14082. Epub 2017 Oct 6.
- Background: PubMed 29135593Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.
- Background: PubMed 29787409Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
- Background: PubMed 30638922Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Regional Anesthesia Morbidity, run by Seoul National University Hospital 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 2 inclusion and 5 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 23 Sep 2019. 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?
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?
Successful perfomance of spinal anesthesia (time frame: Assessed at time of spinal anesthetic injection (baseline)). 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 NCT04001387, which also lists 8 linked publications.
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 23 Sep 2019.