Anesthesia, SpinalNCT03316352
Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
A study testing Ultrasound-assisted paramedian technique spinal anesthesia, Landmark-guided paramedian technique spinal anesthesia and Ultrasound in people with Anesthesia, Spinal and Ultrasonography, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anesthesia, Spinal, Ultrasonography
- What is being tested?
- Ultrasound-assisted paramedian technique spinal anesthesia, Landmark-guided paramedian technique spinal anesthesia and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2017to 11 Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
- Patients 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 spine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.
- Conditions
- Anesthesia, Spinal, Ultrasonography
- Being tested
- Ultrasound-assisted paramedian technique spinal anesthesia, Landmark-guided paramedian technique spinal anesthesia, Ultrasound, 0.5% heavy bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-assisted paramedian technique spinal anesthesiaProcedure or surgery
Also called sono-assisted
Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.
Landmark-guided paramedian technique spinal anesthesiaProcedure or surgery
Also called conventional
Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.
UltrasoundDevice
Also called sonography
A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).
0.5% heavy bupivacaineDrug
Also called bupivacaine
During spinal anesthesia, 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 | Ultrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space. Receives: Procedure: Ultrasound-assisted paramedian technique spinal anesthesia; Device: Ultrasound; Drug: 0.5% heavy bupivacaine |
| Landmark-guided | Active comparator | In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space. Receives: Procedure: Landmark-guided paramedian technique 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: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Time taken for performing spinal anesthetic
time from needle insertion to the completion of injection
Measured: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Level of block
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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Periprocedural pain
11-point verbal rating scale (0=no pain, 10=most pain imaginable)
Measured: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Periprocedural discomfort score
11-point verbal rating scale (0=no discomfort, 10=most discomfort imaginable)
Measured: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start24 Oct 2017
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- NCT03316352
- Sponsor's protocol ID
- 1708-113-879
- Status last verified
- Aug 2018
- First submitted
- 16 Oct 2017
- Last updated
- 31 Aug 2018
- 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 26270115Chin 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 21572316Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.
PubMed 31188153
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT03316352
- Acronym / sponsor ID
- 1708-113-879
- Conditions
- Anesthesia, Spinal, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 20 Oct 2017 (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.
Multiple passes and attempts during spinal anesthesia might be associated with a greater incidence of paraesthesia, postdural puncture headache, and spinal hematoma. We hypothesized that the use of a preprocedural ultrasound-assisted paramedian technique for spinal anesthesia in patients with old age would reduce the number of passes required to entry into the subarachnoid space when compared with the landmark-guided paramedian approach. The study participants will be randomized into group L (landmark-guided) and group U (ultrasound-assisted). In group L, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. In group U, a preprocedural ultrasound scan will be used to mark the needle insertion site, and spinal anesthetic will be done via the paramedian approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted | Experimental | Procedure: Ultrasound-assisted paramedian technique spinal anesthesia, Device: Ultrasound, Drug: 0.5% heavy bupivacaineUltrasound-assisted paramedian technique spinal anesthesia will be performed. A Preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space. |
| Landmark-guided | Active comparator | Procedure: Landmark-guided paramedian technique spinal anesthesia, Drug: 0.5% heavy bupivacaineIn these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. Landmark-guided paramedian technique spinal anesthesia will be performed. 0.5% heavy bupivacaine will be administered into intrathecal space. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly patients (age≥60 years) scheduled to undergoing elective orthopedic surgery under spinal anesthesia
- Patients with ASA physical status classification I, II, III
Key exclusion criteria (4 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 spine surgery
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 technique spinal anesthesiaAlso: sono-assistedUltrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach. | Procedure or surgery | Ultrasound-assisted |
| Landmark-guided paramedian technique spinal anesthesiaAlso: conventionalLandmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique. | Procedure or surgery | Landmark-guided |
| UltrasoundAlso: sonographyA preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range). | Device | Ultrasound-assisted |
| 0.5% heavy bupivacaineAlso: bupivacaineDuring spinal anesthesia, 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. | Drug | Landmark-guided, Ultrasound-assisted |
Primary outcome
the number of needle passes
Time frame: from the initiation of spinal anesthesia procedure, 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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Time for identifying landmarks
Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Time taken for performing spinal anesthetic
Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Level of 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: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Periprocedural pain
Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
Periprocedural discomfort score
Time frame: from the initiation of spinal anesthesia procedure, until the completion of spinal anesthetic injection
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 31 Aug 2018.
- 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.
- 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.
- Derived from this study: PubMed 31188153Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.
- 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 paramedian technique spinal anesthesia, Landmark-guided paramedian technique spinal anesthesia and Ultrasound 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 2 inclusion and 4 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 31 Aug 2018. 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: from the initiation of spinal anesthesia procedure, 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 NCT03316352, which also lists 3 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 31 Aug 2018.