Median and Paramedian Approach in Spinal Anesthesia

Efficacy, Self Clinical Trial

Official title:

Evaluation of Median and Paramedian Approach in Spinal Anesthesia in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750877
• Other study ID #: +90
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: February 22, 2020

Study information

• Verified date: January 2022
• Source: Trabzon Kanuni Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 22, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Efficacy, Self
• Geriatric Patients

Intervention

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

Locations

Country	Name	City	State
Turkey	TRABZON	Yomra

Sponsors (1)

Lead Sponsor	Collaborator
Trabzon Kanuni Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	success rate of spinal needle insertion	The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.	during the procedure of spinal anesthesia
Secondary	Complications of the procedure	complications of spinal anesthesia will be evaluated, during spinal anesthesia and during the first week	during the procedure of spinal anesthesia and 1 week after spinal anesthesia

External 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'.