Vertebral Disc Degenerative DiseaseNCT05414604
Calculating the Volume of the Paravertebral Space
An observational study of Vertebral Disc Degenerative Disease, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Volume of the paravertebral spaces of the tharic and lumbar regions will be measured. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vertebral Disc Degenerative Disease
- What is being tested?
- 3D spine CT
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 1 Aug 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients who had a spine CT scan in our hospital due to vertebral disc degenerative disease
Who may be able to join
- Patients who had a CT scan of the spine in our hospital
Who cannot join
- Patients with scoliosis or known vertebral abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calculating the Volume of the Paravertebral Space With 3D Computerized Tomography
Volume of the paravertebral spaces of the tharic and lumbar regions will be measured.
Read the detailed description
Paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. In addition, paravertebral block is a volume dependent technique. However, there are few cadaveric studies that investigates the volume of the paravertebral space.
This study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3D computerized scan in Kocaeli University Hospital.
- Conditions
- Vertebral Disc Degenerative Disease
- Being tested
- 3D spine CT
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D spine CTDiagnostic test
CT scan of the spine
| Study group | Role | What they receive |
|---|---|---|
| PV group | Patients who had a spine CT Receives: Diagnostic Test: 3D spine CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar paravertebral space
Volume of the paravertebral space of the lumbar region
Measured: Baseline
Thoracic paravertebral space
Volume of the paravertebral space of the thoracic region
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start15 Jun 2022
- Primary completion15 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Disc Degenerative DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414604
- Sponsor's protocol ID
- GOKAEK-2021/16.20
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calculating the Volume of the Paravertebral Space With 3D Computerized Tomography
- ClinicalTrials.gov ID
- NCT05414604
- Acronym / sponsor ID
- GOKAEK-2021/16.20
- Conditions
- Vertebral Disc Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 10 Jun 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.
Volume of the paravertebral spaces of the tharic and lumbar regions will be measured.
Detailed description
Paravertebral block is an effective regional anesthesia method and a golden standart technique for various operations. In addition, paravertebral block is a volume dependent technique. However, there are few cadaveric studies that investigates the volume of the paravertebral space.
This study aims to calculate the volume of the paravertebral spaces of the lumbar and thoracic regions in the patients who had 3D computerized scan in Kocaeli University Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PV group | – | Diagnostic Test: 3D spine CTPatients who had a spine CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had a spine CT scan in our hospital due to vertebral disc degenerative disease
Key inclusion criteria (1 listed)
- Patients who had a CT scan of the spine in our hospital
Key exclusion criteria (1 listed)
- Patients with scoliosis or known vertebral abnormalities
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 |
|---|---|---|
| 3D spine CTCT scan of the spine | Diagnostic test | PV group |
Primary outcome
Lumbar paravertebral space
Time frame: Baseline
Volume of the paravertebral space of the lumbar region
Thoracic paravertebral space
Time frame: Baseline
Volume of the paravertebral space of the thoracic region
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 17 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Disc Degenerative Disease, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 1 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 17 Aug 2022. 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 Turkey (Türkiye). 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?
Lumbar paravertebral space (time frame: Baseline). 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 17 Aug 2022.