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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04092478
Other study ID # YTire
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 23, 2019
Est. completion date January 31, 2020

Study information

Verified date September 2020
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 31, 2020
Est. primary completion date January 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over the age of 18

- Undergo elective surgery

Exclusion Criteria:

- Patients with vertebral anomaly

- Patient with not communicated

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spinal Anesthesia Position
The patient positions during the spinal anesthesia

Locations

Country Name City State
Turkey Yasin Tire Konya Meram

Sponsors (1)

Lead Sponsor Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inter spinal distance Increasing of the Inter spinal distance Through study completion, an average of 6 months.
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