Regional Anesthesia MorbiditycesareanNCT03740399
Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia
A study testing spinal anesthesia in people with Regional Anesthesia Morbidity, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2018to 28 Jun 2019
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- caesarean section
- 18-50 years old
- ASA I-II risk
Who cannot join
- heart failure
- patient's refusal
- thrombocytopenia
- coagulation disorder
- heart valve diseases
Trial locations and contacts
1 site in 1 country.
Beyhan Karamanlıoglu contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, Centrum, 22030
Sevtap Hekimoglu Sahin, Professor, sevtaphekimoglu@mynet.com
Beyhan Karamanlıoglu, Professor, beykar@mynet.com
About this study
The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.
Read the detailed description
180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- spinal anesthesia
- Keywords
- sitting position, lateral decubitus position, spinal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Investigators will perform spinal anesthesia for section
| Study group | Role | What they receive |
|---|---|---|
| Group sitting | Active comparator | we are performing spinal anesthesia in sitting position pregnant patients Receives: Procedure: spinal anesthesia |
| Group lateral decubitus position | Active comparator | we are performing spinal anesthesia in lateral decubitus position pregnant patients Receives: Procedure: spinal anesthesia |
| Group Modified 45-degree head-up tilt | Active comparator | we are performing spinal anesthesia in Modified 45-degree head-up tilt position pregnant patients Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
spinal anesthesia success
The free flow of clear cerebrospinal fluid (CSF) upon first attempt was considered to be evidence of a successful LP.
Measured: spinal anesthesia success will be 15 minutes in intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start19 Apr 2018
- Primary completion28 Mar 2019 (estimated)
- Study completion28 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Hekimoglu Sahin, Trakya University
- Investigators
- Sevtap Hekimoglu Sahin, Proffesor, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740399
- Sponsor's protocol ID
- TÜTF-BAEK 2018/79
- Acronym
- cesarean
- Status last verified
- Nov 2018
- First submitted
- 19 Oct 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03740399
- Acronym / sponsor ID
- cesarean / TÜTF-BAEK 2018/79
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- sitting position, lateral decubitus position, spinal block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 28 Mar 2019 (estimated)
- Study completion
- 28 Jun 2019 (estimated)
- First posted
- 14 Nov 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.
The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.
Detailed description
180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group sitting | Active comparator | Procedure: spinal anesthesiawe are performing spinal anesthesia in sitting position pregnant patients |
| Group lateral decubitus position | Active comparator | Procedure: spinal anesthesiawe are performing spinal anesthesia in lateral decubitus position pregnant patients |
| Group Modified 45-degree head-up tilt | Active comparator | Procedure: spinal anesthesiawe are performing spinal anesthesia in Modified 45-degree head-up tilt position pregnant patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- caesarean section
- 18-50 years old
- ASA I-II risk
Key exclusion criteria (5 listed)
- heart failure
- patient's refusal
- thrombocytopenia
- coagulation disorder
- heart valve diseases
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 anesthesiaInvestigators will perform spinal anesthesia for section | Procedure or surgery | Group Modified 45-degree head-up tilt, Group lateral decubitus position, Group sitting |
Primary outcome
spinal anesthesia success
Time frame: spinal anesthesia success will be 15 minutes in intraoperative
The free flow of clear cerebrospinal fluid (CSF) upon first attempt was considered to be evidence of a successful LP.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
Beyhan Karamanlıoglu contact
Sevtap Hekimoglu Sahin, Proffesor principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia in people with Regional Anesthesia Morbidity, run by Trakya 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 3 inclusion and 5 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 14 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevtap Hekimoglu Sahin, Professor (+90-284-235-76-41, sevtaphekimoglu@mynet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spinal anesthesia success (time frame: spinal anesthesia success will be 15 minutes in intraoperative). 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 14 Nov 2018.