Clinical trial NCT03750877: Median and Paramedian Approach in Spinal Anesthesia
Official title: Evaluation of Median and Paramedian Approach in Spinal Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Patients
Efficacy, Self
Keywords: median approach
paramedian approach
geriatric patient
spinal anesthesia
Lead sponsor: Trabzon Kanuni Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: spinal needle touches the spinal bone
timeFrame: during the procedure of spinal anesthesia
measure: Number of repeated attempts (attempts):
timeFrame: during the procedure of spinal anesthesia
measure: duration of procedure
timeFrame: during the procedure of spinal anesthesia
Secondary outcomes:
measure: success rate of spinal needle insertion
timeFrame: during the procedure of spinal anesthesia
measure: Complications of the procedure
timeFrame: during the procedure of spinal anesthesia and 1 week after spinal anesthesia
Other outcomes:
Locations:
city: Yomra
country: Turkey
facility: TRABZON
Study officials:
affiliation: Trabzon Kanuni Eğitim araştırma Hastanesi
name: Hülya Kılıç Yılmaz
role: STUDY_CHAIR
References: