Anesthesia, SpinalNCT04092478
'' Abdominal Crunch Positions With the Others in Terms of Interspinous Distance in Adult Patients ''
An observational study of Anesthesia, Spinal, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- Spinal Anesthesia Position
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2019to 31 Jan 2020
- How long will I take part?
- 2 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.
Who may be able to join
- Patients over the age of 18
- Undergo elective surgery
Who cannot join
- Patients with vertebral anomaly
- Patient with not communicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ''Compare Abdominal Crunch Positions With Conventional Sitting and Lateral Decubitus Positions in Terms of Interspinous Distance in Adult Patients''
The most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion.
In a study by Martha L Walker et al., The maximum extension of the knees, adduction of the hip, and a modified sitting position with the back flexion, ie, the abdominal crunch position, were found to be effective in increasing the flexion of the lumbar spine.
In our study, we aimed to measure the interspinal distance with the abdominal crunch position with the help of ultrasonography (USG) and to compare the interspinal distance with the measurements obtained in traditional positions (sitting position and lateral decubitus).
Read the detailed description
Interspinal distance will be measured by ultrasonography by 3 different positions, respectively, for the patients who will undergo elective surgery and meet the study criteria and give voluntary consent.
This evaluation process is to record and compare the measurement results. Patients will not undergo any interventional procedures.
Patients who have difficulty in positioning due to hip, femur, knee and tibial fractures or arthrosis and who cannot be communicated will not be included in the study.
One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.
- Conditions
- Anesthesia, Spinal
- Being tested
- Spinal Anesthesia Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia PositionOther
The patient positions during the spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Traditional Sitting Position | We are going to use the Traditional Sitting Position on each patients. Receives: Other: Spinal Anesthesia Position | |
| Lateral Decubitis Position | We are going to use the Lateral Decubitis Position on each patients. Receives: Other: Spinal Anesthesia Position | |
| Abdominal Crunch Position | We are going to use the Abdominal Crunch Position on each patients. Receives: Other: Spinal Anesthesia Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter spinal distance
Increasing of the Inter spinal distance
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start23 Oct 2019
- Primary completion8 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin TİRE, Konya Meram State Hospital
- Investigators
- Yasin Tire, MD, Principal investigator, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092478
- Sponsor's protocol ID
- YTire
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2019
- Last updated
- 16 Sep 2020
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''Compare Abdominal Crunch Positions With Conventional Sitting and Lateral Decubitus Positions in Terms of Interspinous Distance in Adult Patients''
- ClinicalTrials.gov ID
- NCT04092478
- Acronym / sponsor ID
- YTire
- Conditions
- Anesthesia, Spinal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Sep 2019 (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 most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion.
In a study by Martha L Walker et al., The maximum extension of the knees, adduction of the hip, and a modified sitting position with the back flexion, ie, the abdominal crunch position, were found to be effective in increasing the flexion of the lumbar spine.
In our study, we aimed to measure the interspinal distance with the abdominal crunch position with the help of ultrasonography (USG) and to compare the interspinal distance with the measurements obtained in traditional positions (sitting position and lateral decubitus).
Detailed description
Interspinal distance will be measured by ultrasonography by 3 different positions, respectively, for the patients who will undergo elective surgery and meet the study criteria and give voluntary consent.
This evaluation process is to record and compare the measurement results. Patients will not undergo any interventional procedures.
Patients who have difficulty in positioning due to hip, femur, knee and tibial fractures or arthrosis and who cannot be communicated will not be included in the study.
One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Sitting Position | – | Other: Spinal Anesthesia PositionWe are going to use the Traditional Sitting Position on each patients. |
| Lateral Decubitis Position | – | Other: Spinal Anesthesia PositionWe are going to use the Lateral Decubitis Position on each patients. |
| Abdominal Crunch Position | – | Other: Spinal Anesthesia PositionWe are going to use the Abdominal Crunch Position on each patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Undergo elective surgery
Key exclusion criteria (2 listed)
- Patients with vertebral anomaly
- Patient with not communicated
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 PositionThe patient positions during the spinal anesthesia | Other | Abdominal Crunch Position, Lateral Decubitis Position, Traditional Sitting Position |
Primary outcome
Inter spinal distance
Time frame: Through study completion, an average of 6 months.
Increasing of the Inter spinal distance
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 16 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Spinal
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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.
Yasin Tire, MD principal investigator
Konya Meram State Hospital
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 Anesthesia, Spinal, run by Konya Meram State Hospital 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 2 inclusion and 2 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 16 Sep 2020. 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?
Inter spinal distance (time frame: Through study completion, an average of 6 months.). 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 16 Sep 2020.