Regional Anesthesia MorbidityNCT03805958
Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan
A study testing realtime ultrasonography and prescan ultrasonography in people with Regional Anesthesia Morbidity and Ultrasonography, run by Seoul National University Hospital.
Trial summary
The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity, Ultrasonography
- What is being tested?
- realtime ultrasonography and prescan ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2019to 15 Jan 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal/Epidural combined anesthesia is required.
Who cannot join
- Skin infection or trauma
- Abnormal coagulation lab
- History of spine surgery
- Pregnancy
- Abnormal structure of spine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan
The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.
Read the detailed description
Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction.
- Conditions
- Regional Anesthesia Morbidity, Ultrasonography
- Being tested
- realtime ultrasonography, prescan ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
realtime ultrasonographyProcedure or surgery
Applying realtime ultrasound during the combined anesthesia
prescan ultrasonographyProcedure or surgery
Applying realtime ultrasound before the combined anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Pre-procedure | Experimental | Confirmed landmark by ultrasound scan before procedure Receives: Procedure: prescan ultrasonography |
| Real time | Active comparator | Confirmed landmark by ultrasound scan during procedure Receives: Procedure: realtime ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle pass
Number of needle pass
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start15 Nov 2019 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 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
- Investigators
- Tae Kyong Kim, Kim, Study director, SMG-SNU Boramae hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805958
- Sponsor's protocol ID
- 30-2018-81
- Status last verified
- Sep 2019
- First submitted
- 13 Jan 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 17350519
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
- A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan
- ClinicalTrials.gov ID
- NCT03805958
- Acronym / sponsor ID
- 30-2018-81
- Conditions
- Regional Anesthesia Morbidity, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2019 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 16 Jan 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 investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.
Detailed description
Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-procedure | Experimental | Procedure: prescan ultrasonographyConfirmed landmark by ultrasound scan before procedure |
| Real time | Active comparator | Procedure: realtime ultrasonographyConfirmed landmark by ultrasound scan during procedure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spinal/Epidural combined anesthesia is required.
Key exclusion criteria (5 listed)
- Skin infection or trauma
- Abnormal coagulation lab
- History of spine surgery
- Pregnancy
- Abnormal structure of spine
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 |
|---|---|---|
| realtime ultrasonographyApplying realtime ultrasound during the combined anesthesia | Procedure or surgery | Real time |
| prescan ultrasonographyApplying realtime ultrasound before the combined anesthesia | Procedure or surgery | Pre-procedure |
Primary outcome
Number of needle pass
Time frame: intraoperative
Number of needle pass
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.
- 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.
Tae Kyong Kim, Kim study director
SMG-SNU Boramae hospital
Questions about this trial
What is this clinical trial studying?
A study testing realtime ultrasonography and prescan ultrasonography in people with Regional Anesthesia Morbidity and Ultrasonography, run by Seoul National University Hospital.
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 1 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.
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?
Contact Tae Kyong Kim, MD, phD (+82-2-870-2519, ktkktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of needle pass (time frame: intraoperative). 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 NCT03805958, which also lists 2 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.