Spinal Needle Diameter and Design, Click FeelingNCT05704816
The Effect of Different Types of Spinal Needles on the Success of the Procedure
An observational study of Spinal Needle Diameter and Design, Click Feeling, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Needle Diameter and Design, Click Feeling
- What is being tested?
- Spinal anesthesia application
- How many people
- 213 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Nov 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 213
Who may be able to join
- Elective lower abdomen/extremity surgery planned,
- American Society of Anesthesiologists (ASA) I-II risk group,
- without bleeding diathesis
- patients with written consent
Who cannot join
- Patients for whom spinal anesthesia is contraindicated,
- morbidly obese,
- pregnant
- Patients with a history of allergic reactions to the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling.
- Being tested
- Spinal anesthesia application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia applicationOther
The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
| Study group | Role | What they receive |
|---|---|---|
| Quincke (Q)-25 Gauge | Not described Receives: Other: Spinal anesthesia application | |
| Quincke (Q)-26Gauge | Not described Receives: Other: Spinal anesthesia application | |
| Quincke (Q)-27 Gauge | Not described Receives: Other: Spinal anesthesia application | |
| Pencil-point (P)-25Gauge | Not described Receives: Other: Spinal anesthesia application | |
| Pencil-point (P)-26Gauge | Not described Receives: Other: Spinal anesthesia application | |
| Pencil-point (P)-27Gauge | Not described Receives: Other: Spinal anesthesia application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Clicking feeling: Considering that the click feeling due to dural puncture is taken, in which attempt (1, 2, and ≥3) the needle's guide was removed and the cerebrospinal fluid (CSF) arrival occurred Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)
Measured: Spinal anesthesia procedure time
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)
Measured: Spinal anesthesia procedure time
Secondary outcomes (1)
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
First-year anesthesia assistants get a click feeling with needles with different tip designs and diameters
Measured: Spinal anesthesia procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Needle Diameter and Design, Click FeelingStudies 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Küçükosman, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704816
- Sponsor's protocol ID
- 2018/20
- Status last verified
- Jan 2023
- First submitted
- 3 Oct 2022
- Last updated
- 30 Jan 2023
- Results posted
- 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 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05704816
- Acronym / sponsor ID
- 2018/20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 30 Jan 2023 (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.
The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Quincke (Q)-25 Gauge | – | Other: Spinal anesthesia application |
| Quincke (Q)-26Gauge | – | Other: Spinal anesthesia application |
| Quincke (Q)-27 Gauge | – | Other: Spinal anesthesia application |
| Pencil-point (P)-25Gauge | – | Other: Spinal anesthesia application |
| Pencil-point (P)-26Gauge | – | Other: Spinal anesthesia application |
| Pencil-point (P)-27Gauge | – | Other: Spinal anesthesia application |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 213
Key inclusion criteria (4 listed)
- Elective lower abdomen/extremity surgery planned,
- American Society of Anesthesiologists (ASA) I-II risk group,
- without bleeding diathesis
- patients with written consent
Key exclusion criteria (4 listed)
- Patients for whom spinal anesthesia is contraindicated,
- morbidly obese,
- pregnant
- Patients with a history of allergic reactions to the drugs used in the study.
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 |
|---|---|---|
| Spinal anesthesia applicationThe success of the needles with different tip designs and thicknesses used in spinal anesthesia application | Other | Pencil-point (P)-25Gauge, Pencil-point (P)-26Gauge, Pencil-point (P)-27Gauge, Quincke (Q)-25 Gauge, Quincke (Q)-26Gauge, Quincke (Q)-27 Gauge |
Primary outcome
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Time frame: Spinal anesthesia procedure time
Clicking feeling: Considering that the click feeling due to dural puncture is taken, in which attempt (1, 2, and ≥3) the needle's guide was removed and the cerebrospinal fluid (CSF) arrival occurred Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Time frame: Spinal anesthesia procedure time
Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)
1 secondary outcome
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Time frame: Spinal anesthesia procedure time
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 30 Jan 2023.
- Individual participant dataSharing planned: No
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 Spinal Needle Diameter and Design, Click Feeling, run by Zonguldak Bulent Ecevit 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 4 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 30 Jan 2023. 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?
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study (time frame: Spinal anesthesia procedure time). 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 30 Jan 2023.