Median and Paramedian Approach in Spinal Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Efficacy, Self; Geriatric Patients
• Intervention / Treatment: Procedure: median approach; Procedure: paramedian approach

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yomra, Turkey, 61500
    • TRABZON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: median approach; Spinal anesthesia will be performed with a conventional median approach	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.; Other Names: classical approach; Procedure: paramedian approach; In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.
Active Comparator: paramedian approach; Spinal anesthesia will be applied with a paramedian approach.	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.; Other Names: classical approach; Procedure: paramedian approach; In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Trabzon Kanuni Education and Research Hospital
• Investigators: Study Chair: Hülya Kılıç Yılmaz, Trabzon Kanuni Eğitim araştırma Hastanesi

Publications and helpful links

Helpful 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 record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): February 22, 2020

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: spinal anesthesia; median approach; paramedian approach; geriatric patient
• Other Study ID Numbers: +90

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: stated that the personal data will not be shared in the participant consent form in the study design.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No