Anesthesia, SpinalNCT03491943
Midline vs. Paramedian Approaches for US-assisted Spinal Anesthesia
A study testing ultrasound-assisted midline approach and ultrasound-assisted paramedian approach in people with Anesthesia, Spinal and Ultrasonography, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Spinal, Ultrasonography
- What is being tested?
- ultrasound-assisted midline approach and ultrasound-assisted paramedian approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2018to 9 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III
Who cannot join
- Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- Patients with morbid cardiac diseases
- Pregnancy
- Patients with previous history of lumbar spinal surgery
- Patients with anatomical abnormality of lumbar spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.
- Conditions
- Anesthesia, Spinal, Ultrasonography
- Being tested
- ultrasound-assisted midline approach, ultrasound-assisted paramedian approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-assisted midline approachProcedure or surgery
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via midline approach.
ultrasound-assisted paramedian approachProcedure or surgery
A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.
| Study group | Role | What they receive |
|---|---|---|
| Midline group | Experimental | Preprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. Receives: Procedure: ultrasound-assisted midline approach |
| Paramedian group | Active comparator | Preprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. Receives: Procedure: ultrasound-assisted paramedian approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of needle passes
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin
Measured: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Secondary outcomes (8)
Number of spinal needle insertion attempts
the number of times the spinal needle was withdrawn from the skin and reinserted
Measured: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Time for identifying landmarks
time from placement of the ultrasound probe on the skin to the completion of markings.
Measured: intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning
Time taken for performing spinal anesthetic
time from needle insertion to the completion of injection
Measured: Intraoperative (from insertion of the needle to the completion of injection)
dermatome level of sensory block
thoracic dermatome level of sensory block assessed by loss of cold sensation tested with 2% chlorhexidine swab
Measured: 20 minutes after the completion of spinal anesthetic injection
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle during the spinal anesthesia procedure
Measured: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Periprocedural pain
11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Measured: Patients will be asked immediately after the completion of spinal anesthesia
Periprocedural discomfort score
11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Measured: Patients will be asked immediately after the completion of spinal anesthesia
Patient satisfaction score of spinal anesthesia procedure
11-point verbal rating scale (0=very unsatisfied, 10=very satisfied)
Measured: Patients will be asked immediately after the completion of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start27 Apr 2018
- Primary completion8 Oct 2018
- Study completion9 Oct 2018
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 Anesthesia, SpinalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491943
- Sponsor's protocol ID
- H-1803-060-928
- Status last verified
- Dec 2019
- First submitted
- 2 Apr 2018
- Last updated
- 23 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-1096. doi: 10.1213/ANE.0000000000000911.
PubMed 26270115Park SK, Cheun H, Kim YW, Bae J, Yoo S, Kim WH, Lim YJ, Kim JT. Ultrasound-assisted spinal anesthesia: A randomized comparison between midline and paramedian approaches. J Clin Anesth. 2022 Sep;80:110823. doi: 10.1016/j.jclinane.2022.110823. Epub 2022 Apr 11.
PubMed 35421679
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Versus Paramedian Approaches for Ultrasound-assisted Spinal Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03491943
- Acronym / sponsor ID
- H-1803-060-928
- Conditions
- Anesthesia, Spinal, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 9 Apr 2018 (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.
Ultrasound has emerged as an useful tool for neuraxial blockade. The aim of this study is to compare the efficacy and safety between the midline approach and paramedian approach for ultrasound-assisted spinal anesthesia in adult patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline group | Experimental | Procedure: ultrasound-assisted midline approachPreprocedural ultrasound-assisted midline approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. |
| Paramedian group | Active comparator | Procedure: ultrasound-assisted paramedian approachPreprocedural ultrasound-assisted paramedian approach of spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia, with ASA physical status classification I, II, III
Key exclusion criteria (5 listed)
- Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- Patients with morbid cardiac diseases
- Pregnancy
- Patients with previous history of lumbar spinal surgery
- Patients with anatomical abnormality of lumbar 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 |
|---|---|---|
| ultrasound-assisted midline approachA preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via midline approach. | Procedure or surgery | Midline group |
| ultrasound-assisted paramedian approachA preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach. | Procedure or surgery | Paramedian group |
Primary outcome
the number of needle passes
Time frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin
8 secondary outcomes
Number of spinal needle insertion attempts
Time frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
Time for identifying landmarks
Time frame: intraoperative (time taken for establish the landmark, from start of US scanning to completion of scanning
Time taken for performing spinal anesthetic
Time frame: Intraoperative (from insertion of the needle to the completion of injection)
dermatome level of sensory block
Time frame: 20 minutes after the completion of spinal anesthetic injection
Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle
Time frame: Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection)
Periprocedural pain
Time frame: Patients will be asked immediately after the completion of spinal anesthesia
Periprocedural discomfort score
Time frame: Patients will be asked immediately after the completion of spinal anesthesia
Patient satisfaction score of spinal anesthesia procedure
Time frame: Patients will be asked immediately after the completion of spinal anesthesia
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 23 Dec 2019.
- Background: PubMed 26270115Kallidaikurichi Srinivasan K, Iohom G, Loughnane F, Lee PJ. Conventional Landmark-Guided Midline Versus Preprocedure Ultrasound-Guided Paramedian Techniques in Spinal Anesthesia. Anesth Analg. 2015 Oct;121(4):1089-1096. doi: 10.1213/ANE.0000000000000911.
- Derived from this study: PubMed 35421679Park SK, Cheun H, Kim YW, Bae J, Yoo S, Kim WH, Lim YJ, Kim JT. Ultrasound-assisted spinal anesthesia: A randomized comparison between midline and paramedian approaches. J Clin Anesth. 2022 Sep;80:110823. doi: 10.1016/j.jclinane.2022.110823. Epub 2022 Apr 11.
- 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.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
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-assisted midline approach and ultrasound-assisted paramedian approach in people with Anesthesia, Spinal and Ultrasonography, 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 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: finished, as of the sponsor's last update on 23 Dec 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?
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 number of needle passes (time frame: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)). 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 NCT03491943, 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 Dec 2019.