Erector Spina Muscle Distance From the Skin at Different... | NCT06129305

Studies
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations

NCT06129305

Sponsor

Konya City Hospital

Status

Completed

Last Update Posted

Nov 13, 2023Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Pain, Postoperative
Pain, Back

Interventions

Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2021Actual

Primary Completion Date

Sep 6, 2022Actual

Completion Date

Dec 6, 2022Actual

First Submitted Date

Aug 14, 2023

First Submission Date that Met QC Criteria

Nov 8, 2023

First Posted Date

Nov 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2023

Last Update Posted Date

Nov 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammed Halit Satici, Specialist, Department of Anesthesiology, Konya City Hospital, M.D, Konya City HospitalPrincipal Investigator

Lead Sponsor

Konya City HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography	Other	Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	two years

Secondary Outcomes

Measure	Description	Time Frame
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.	two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

18-65 years with ASA (American Society of Anaesthesiologists) I-II patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MUHAMMED H SATICI, M.D.	Konya City Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konya City Hospital		Konya		38000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

We do not have such an opinion.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D001416	Back Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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Browse Branches

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