Median and Paramedian Approach in Spinal Anesthesia

NCT03750877 | Completed

• 1 other identifier: +90
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Geriatric Patients; Efficacy, Self

Keywords

median approach; paramedian approach; geriatric patient; spinal anesthesia

Outcome Measures

Primary Outcomes (3)

• spinal needle touches the spinal bone

  The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.

  during the procedure of spinal anesthesia

• Number of repeated attempts (attempts):

  The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.

  during the procedure of spinal anesthesia

• duration of procedure

  In spinal anesthesia, the time to reach the skin and the spinal area will be evaluated.

  during the procedure of spinal anesthesia

Secondary Outcomes (2)

• success rate of spinal needle insertion

  during the procedure of spinal anesthesia

• Complications of the procedure

  during the procedure of spinal anesthesia and 1 week after spinal anesthesia

Study Arms (2)

median approach

ACTIVE COMPARATOR

Spinal anesthesia will be performed with a conventional median approach

Procedure: median approach; Procedure: paramedian approach

paramedian approach

ACTIVE COMPARATOR

Spinal anesthesia will be applied with a paramedian approach.

Procedure: median approach; Procedure: paramedian approach

Interventions

median approach PROCEDURE

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

Also known as: classical approach

median approach; paramedian approach

paramedian approach PROCEDURE

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

median approach; paramedian approach

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trabzon Kanuni Education and Research Hospital: lead

Study Sites (1)

TRABZON

Yomra, 61500, Turkey (Türkiye)

Location

Related Links

• 'Comparison of Epidrum, Epi-jet, and Loss of Resistance Syringe Techniques for Identifying the Epidural Space in Obstetric Patients'
• 'Paramedian technique of spinal anesthesia in elderly patients for hip fracture surgery'.

Study Officials

• Hülya Kılıç Yılmaz

  Trabzon Kanuni Eğitim araştırma Hastanesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 23, 2018
• Study Start: June 13, 2018
• Primary Completion: November 20, 2019
• Study Completion: February 22, 2020
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)