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Median and Paramedian Approach in Spinal Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03750877
Enrollment
100
Registered
2018-11-23
Start date
2018-06-13
Completion date
2020-02-22
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy, Self, Geriatric Patients

Keywords

median approach, paramedian approach, geriatric patient, spinal anesthesia

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.

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.

Interventions

PROCEDUREmedian approach

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

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

Sponsors

Trabzon Kanuni Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
spinal needle touches the spinal boneduring the procedure of spinal anesthesiaThe ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
Number of repeated attempts (attempts):during the procedure of spinal anesthesiaThe ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
duration of procedureduring the procedure of spinal anesthesiaIn spinal anesthesia, the time to reach the skin and the spinal area will be evaluated.

Secondary

MeasureTime frameDescription
success rate of spinal needle insertionduring the procedure of spinal anesthesiaThe ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.
Complications of the procedureduring the procedure of spinal anesthesia and 1 week after spinal anesthesiacomplications of spinal anesthesia will be evaluated, during spinal anesthesia and during the first week

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026