Evaluation of Median and Paramedian Approach in Spinal Anesthesia in Elderly Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- spinal needle touches the spinal bone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
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.
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
- success rate of spinal needle insertion(during the procedure of spinal anesthesia)
- Complications of the procedure(during the procedure of spinal anesthesia and 1 week after spinal anesthesia)
Investigators
Seyfi KARTAL, MD
Assistant professor
Trabzon Kanuni Education and Research Hospital