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Completed

NCT Number: NCT03750877

Median and Paramedian Approach in Spinal Anesthesia

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.

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Key information

Conditions

Geriatric Patients Efficacy, Self

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TRABZON

Yomra, 61500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: classical approach

paramedian approach

Procedure

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

Primary outcomes

  1. spinal needle touches the spinal bone

    Time frame: during the procedure of spinal anesthesia

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

  2. Number of repeated attempts (attempts):

    Time frame: during the procedure of spinal anesthesia

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

  3. duration of procedure

    Time frame: during the procedure of spinal anesthesia

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

Secondary outcomes

  1. success rate of spinal needle insertion

    Time frame: during the procedure of spinal anesthesia

    The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.

  2. Complications of the procedure

    Time frame: during the procedure of spinal anesthesia and 1 week after spinal anesthesia

    complications of spinal anesthesia will be evaluated, during spinal anesthesia and during the first week

Sponsors and collaborators

Lead sponsor

Trabzon Kanuni Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 23, 2018
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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