Combined Spinal Epidurai AnesthesiaNCT05201261
the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level
An observational study of Combined Spinal Epidurai Anesthesia and Lower Extremity Surgery, run by Shengjing Hospital.
Trial summary
Spinal anesthesia technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Combined Spinal Epidurai Anesthesia, Lower Extremity Surgery
- What is being tested?
- ltrasonic measure
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Feb 2023
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing elective surgery under spinal anesthesia. Inclusion criteria: (1) Elective lower extremity surgery; (3) ASA (American Society of Anesthesiologists) Grading: ⅰ - ⅲ.
Who may be able to join
- Patients undergoing elective lower limbs surgery
- ASA: grade I to III
Who cannot join
- There are contraindications to spinal anesthesia
- Allergic to local anesthetics
- Patient refused
About this study
Spinal anesthesia technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. How to provide perfect nerve block effect for operation, provide good postoperative analgesia, and prevent unnecessary extensive block leading to other complications and related risks has always been the focus of anesthesiologists. Doses and the relationship between the anesthesia plane great individual differences, and previous research on the patient's own condition such as height, weight, 6 to the anesthesia plane have different results, the influence of clinical work often refer patients height adjustment of drug doses, this research attempts to evaluate ultrasound was used to assess spinal vertebral body in the plane of the length and width of subarachnoid and anesthesia.
- Being tested
- ltrasonic measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ltrasonic measureDevice
In the right decubitus position, the spine was scanned with an ultrasonic convex array probe. Starting from the sacrum, the length of each vertebral body of the lumbar spine was measured on a para-midsagittal oblique view. The intervertebral space was located and the width of the subarachnoid space was measured on a midsagittal and transverse view.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided group | Adult patients with American Society of Anesthesiologists physical status I/II/III scheduled to undergo elective Lower limb surgery under spinal anesthesia were considered for eligibility. Receives: Device: ltrasonic measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of lumbar cone
Ultrasound findings
Measured: 1year
The width of subarachnoid space was measured by ultrasound
Ultrasound findings
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Spinal Epidurai AnesthesiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201261
- Sponsor's protocol ID
- block level
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level
- ClinicalTrials.gov ID
- NCT05201261
- Acronym / sponsor ID
- block level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Jan 2022 (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 technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. How to provide perfect nerve block effect for operation, provide good postoperative analgesia, and prevent unnecessary extensive block leading to other complications and related risks has always been the focus of anesthesiologists. Doses and the relationship between the anesthesia plane great individual differences, and previous research on the patient's own condition such as height, weight, 6 to the anesthesia plane have different results, the influence of clinical work often refer patients height adjustment of drug doses, this research attempts to evaluate ultrasound was used to assess spinal vertebral body in the plane of the length and width of subarachnoid and anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided group | – | Device: ltrasonic measureAdult patients with American Society of Anesthesiologists physical status I/II/III scheduled to undergo elective Lower limb surgery under spinal anesthesia were considered for eligibility. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective surgery under spinal anesthesia. Inclusion criteria: (1) Elective lower extremity surgery; (3) ASA (American Society of Anesthesiologists) Grading: ⅰ - ⅲ.
Key inclusion criteria (2 listed)
- Patients undergoing elective lower limbs surgery
- ASA: grade I to III
Key exclusion criteria (3 listed)
- There are contraindications to spinal anesthesia
- Allergic to local anesthetics
- Patient refused
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 |
|---|---|---|
| ltrasonic measureIn the right decubitus position, the spine was scanned with an ultrasonic convex array probe. Starting from the sacrum, the length of each vertebral body of the lumbar spine was measured on a para-midsagittal oblique view. The intervertebral space was located and the width of the subarachnoid space was measured on a midsagittal and transverse view. | Device | Ultrasound-guided group |
Primary outcome
The length of lumbar cone
Time frame: 1year
Ultrasound findings
The width of subarachnoid space was measured by ultrasound
Time frame: 1year
Ultrasound findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Spinal Epidurai Anesthesia and Lower Extremity Surgery, run by Shengjing 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 2 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. 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?
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 length of lumbar cone (time frame: 1year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.