Anesthesia, SpinalNCT03459105
Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
A study testing Ultrasound-assisted paramedian spinal anesthesia, Landmark-guided spinal anesthesia and 0.5% heavy bupivacaine in people with Anesthesia, Spinal and Ultrasonography, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Spinal, Ultrasonography, Scoliosis
- What is being tested?
- Ultrasound-assisted paramedian spinal anesthesia, Landmark-guided spinal anesthesia and 0.5% heavy bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Mar 2018to 5 Jul 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,
- and with (1) or (2)
- documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle > 10 degree)
- previous history of lumbar spinal surgery
Who cannot join
- Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- Patients with morbid cardiac diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.
- Conditions
- Anesthesia, Spinal, Ultrasonography, Scoliosis
- Being tested
- Ultrasound-assisted paramedian spinal anesthesia, Landmark-guided spinal anesthesia, 0.5% heavy bupivacaine
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted paramedian spinal anesthesiaProcedure or surgery
Also called sono-assisted
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.
Landmark-guided spinal anesthesiaProcedure or surgery
Also called conventional
Spinal anesthesia will be done using conventional landmark-guided technique.
0.5% heavy bupivacaineDrug
Also called bupivacaine
0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted | Experimental | Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. Receives: Procedure: Ultrasound-assisted paramedian spinal anesthesia; Drug: 0.5% heavy bupivacaine |
| Landmark-guided | Active comparator | Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. Receives: Procedure: Landmark-guided spinal anesthesia; Drug: 0.5% heavy bupivacaine |
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 (7)
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
In group L, time from start of palpation to completion of the process, as declared by the anesthesiologist. In group U, time from placement of the ultrasound probe on the skin to the completion of markings.
Measured: 1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/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: 5, 10, 15 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start13 Mar 2018
- Primary completion4 Jul 2018
- Study completion5 Jul 2018
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 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
- NCT03459105
- Sponsor's protocol ID
- 1801-107-917
- Status last verified
- Jan 2019
- First submitted
- 27 Feb 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
PubMed 21572316
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
- ClinicalTrials.gov ID
- NCT03459105
- Acronym / sponsor ID
- 1801-107-917
- Conditions
- Anesthesia, Spinal, Ultrasonography, Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 8 Mar 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.
Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted | Experimental | Procedure: Ultrasound-assisted paramedian spinal anesthesia, Drug: 0.5% heavy bupivacainePreprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia. |
| Landmark-guided | Active comparator | Procedure: Landmark-guided spinal anesthesia, Drug: 0.5% heavy bupivacaineLandmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 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 (5 listed)
- Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia,
- with ASA physical status classification I, II, III,
- and with (1) or (2)
Key exclusion criteria (3 listed)
- Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- Patients with morbid cardiac diseases
- Pregnancy
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 paramedian spinal anesthesiaAlso: sono-assistedA 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 | Ultrasound-assisted |
| Landmark-guided spinal anesthesiaAlso: conventionalSpinal anesthesia will be done using conventional landmark-guided technique. | Procedure or surgery | Landmark-guided |
| 0.5% heavy bupivacaineAlso: bupivacaine0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg. | Drug | Landmark-guided, Ultrasound-assisted |
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
7 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: 1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/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: 5, 10, 15 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
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 3 Jan 2019.
- Background: PubMed 21572316Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Spinal
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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 paramedian spinal anesthesia, Landmark-guided spinal anesthesia and 0.5% heavy bupivacaine 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 5 inclusion and 3 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 3 Jan 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 NCT03459105, 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 3 Jan 2019.