Pain, PostoperativeNCT06129305
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
An observational study of Pain, Postoperative and Pain, Back, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pain, Back
- What is being tested?
- Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 6 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-65 years with ASA (American Society of Anaesthesiologists) I-II patients
Who may be able to join
- Patients aged 18-65 years ASA (American Society of Anaesthesiologists) I-II who were to undergo cholecystectomy who were to undergo mastectomy who were to undergo inguinal hernia who were to undergo thoracic surgery
Who cannot join
- Patients in whom peripheral nerve block was contraindicated uncooperative patients disabled patients emergency cases patients with scoliosis pregnant and breastfeeding women patients with trauma incision scars in the measured area ASA III-IV-V group patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Distance of the Erector Spina Muscle From the Skin at Different Thoracal Levels and Different posıtıons Under Ultrasonography
In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block.
Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better. Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.
Read the detailed description
1- Abstract Introduction Erector spina plana block can be performed in different positions (sitting-lateral-pron) and at different thoracic levels. In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block. Material and Methods A total of 80 patients (40 females and 40 males, ASA I-II) aged 18-65 years were included in the study. The erector spinae muscle was determined at T1-T2, T5-T6, and T11-T12 levels and in lateral, sitting, and prone positions, respectively, with a high frequency 10-15 millihertz linear probe of ultrasound, The distance from the skin to the midline of the ultrasound screen was measured, and the best ultrasound screen image was recorded. Erector spina plan block, distance measurement, different positions, interfascial plan block.
- Conditions
- Pain, Postoperative, Pain, Back
- Being tested
- Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography
- Keywords
- Erector spinae plane block, interfascial plan block.
- Medical subject headings
- Pain, Postoperative, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonographyOther
Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
distance of the erector spinae muscle from the skin in millimeters
Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better.
Measured: two years
Secondary outcomes (1)
clarity of the erector spinae muscle in different positions
Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start6 Sep 2021
- Primary completion6 Sep 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
- Investigators
- MUHAMMED H SATICI, M.D., Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129305
- Sponsor's protocol ID
- konya city hospital
- Status last verified
- Nov 2023
- First submitted
- 14 Aug 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have such an opinion.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Distance of the Erector Spina Muscle From the Skin at Different Thoracal Levels and Different posıtıons Under Ultrasonography
- ClinicalTrials.gov ID
- NCT06129305
- Acronym / sponsor ID
- konya city hospital
- Conditions
- Pain, Postoperative, Pain, Back
- Keywords
- Erector spinae plane block, interfascial plan block.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 13 Nov 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.
In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block.
Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better. Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.
Detailed description
1- Abstract Introduction Erector spina plana block can be performed in different positions (sitting-lateral-pron) and at different thoracic levels. In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block. Material and Methods A total of 80 patients (40 females and 40 males, ASA I-II) aged 18-65 years were included in the study. The erector spinae muscle was determined at T1-T2, T5-T6, and T11-T12 levels and in lateral, sitting, and prone positions, respectively, with a high frequency 10-15 millihertz linear probe of ultrasound, The distance from the skin to the midline of the ultrasound screen was measured, and the best ultrasound screen image was recorded. Erector spina plan block, distance measurement, different positions, interfascial plan block.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 years with ASA (American Society of Anaesthesiologists) I-II patients
Key inclusion criteria (1 listed)
- Patients aged 18-65 years ASA (American Society of Anaesthesiologists) I-II who were to undergo cholecystectomy who were to undergo mastectomy who were to undergo inguinal hernia who were to undergo thoracic surgery
Key exclusion criteria (1 listed)
- Patients in whom peripheral nerve block was contraindicated uncooperative patients disabled patients emergency cases patients with scoliosis pregnant and breastfeeding women patients with trauma incision scars in the measured area ASA III-IV-V group patients
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 |
|---|---|---|
| Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonographyComparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography | Other | – |
Primary outcome
distance of the erector spinae muscle from the skin in millimeters
Time frame: two years
Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better.
1 secondary outcome
clarity of the erector spinae muscle in different positions
Time frame: two years
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 13 Nov 2023.
- Individual participant dataSharing planned: No. We do not have such an opinion.
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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.
MUHAMMED H SATICI, M.D. principal investigator
Konya City 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 Pain, Postoperative and Pain, Back, run by Konya City 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 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 13 Nov 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?
distance of the erector spinae muscle from the skin in millimeters (time frame: two years). 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 13 Nov 2023.