Median and Paramedian Approach in Spinal Anesthesia

NCT ID: NCT03750877

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2020-02-22

Brief Summary

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Spinal anesthesia (SA) is frequently used as anesthesia in many surgeries such as lower abdominal, inguinal, urogenital, rectal and lower extremities.

Conventional median approach (MA) is preferred more frequently, although MA or paramedian approach (PA) is used in SA. Especially in geriatric patients due to degenerative changes Although we are told that degenerative changes are less affected in PA during SA in the geriatric age group, few studies have been conducted on the subject and we aimed to evaluate the superiority of the two methods.

Detailed Description

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In our study, 100 cases were planned to be evaluated prospectively. Patients scheduled for surgery under spinal anesthesia will undergo routine spinal preparation. After routine motorization, patients will be treated with MA or PA.

MA will be performed in a conventional manner and PA will be performed by adding 1 cm lateral and 1 cm caudal from the planned vertebral space to 10-15 degree medial and cephal.

If one of the patients with MA or PA fails, despite three attempts, the other method will be tried by another specialist. If the procedure fails or there are not enough blocks, a different anesthesia method will be applied.

The data of the patients included in the study were evaluated by a different researcher other than the SA physician; demographic data of the cases, type of operation, MA or PA in SA and the number of repeated attempts / trials for the procedure will be evaluated.

Conditions

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Geriatric Patients Efficacy, Self

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The aim of this study was to evaluate the success rate of median and paramedian approach in spinal anesthesia in geriatric patients, number of trials, number of attempts at another interval due to failure, duration of procedure, patient comfort, change to other method in case of failure and success rate. In the study, two groups were formed: the median approach and the paramedian approach.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
the number of files from the volunteer participants were grouped into one group and the ones with double file numbers were included in the other group.

participants do not know which group of patients to be in. Only practitioners know about the procedure.

Study Groups

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median approach

Spinal anesthesia will be performed with a conventional median approach

Group Type ACTIVE_COMPARATOR

median approach

Intervention Type PROCEDURE

spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.

paramedian approach

Intervention Type PROCEDURE

In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.

paramedian approach

Spinal anesthesia will be applied with a paramedian approach.

Group Type ACTIVE_COMPARATOR

median approach

Intervention Type PROCEDURE

spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.

paramedian approach

Intervention Type PROCEDURE

In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.

Interventions

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median approach

spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.

Intervention Type PROCEDURE

paramedian approach

In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.

Intervention Type PROCEDURE

Other Intervention Names

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classical approach

Eligibility Criteria

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Inclusion Criteria

* Patients older than 70 years
* elective surgery under spinal anesthesia
* those who agreed to participate in the study
* Those with American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria

* who use opioid or other non-steroidal anti-inflammatory drugs regularly
* who are allergic to a drug used in the study
* had contraindications for spinal anesthesia,
* drug addiction
* obese patients (Body Mass Index ≥ 35)
* migraine and chronic headache
* Spinal anesthesia can not be performed in more than 3 trials, but passed to the general anesthesia
* those who do not agree to participate in the study
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trabzon Kanuni Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seyfi KARTAL, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hülya Kılıç Yılmaz

Role: STUDY_CHAIR

Trabzon Kanuni Eğitim araştırma Hastanesi

Locations

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TRABZON

Yomra, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/28891544

'Comparison of Epidrum, Epi-jet, and Loss of Resistance Syringe Techniques for Identifying the Epidural Space in Obstetric Patients'

http://www.ncbi.nlm.nih.gov/pubmed/15808095

'Paramedian technique of spinal anesthesia in elderly patients for hip fracture surgery'.

Other Identifiers

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+90

Identifier Type: -

Identifier Source: org_study_id

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