Geriatric PatientsNCT03750877
Median and Paramedian Approach in Spinal Anesthesia
A study testing median approach and paramedian approach in people with Geriatric Patients and Efficacy, Self, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Patients, Efficacy, Self
- What is being tested?
- median approach and paramedian approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2018to 22 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Patients, Efficacy, Self
- Being tested
- median approach, paramedian approach
- Keywords
- median approach, paramedian approach, geriatric patient, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
median approachProcedure or surgery
Also called classical approach
spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.
paramedian approachProcedure or surgery
In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.
| Study group | Role | What they receive |
|---|---|---|
| median approach | Active comparator | Spinal anesthesia will be performed with a conventional median approach Receives: Procedure: median approach; Procedure: paramedian approach |
| paramedian approach | Active comparator | Spinal anesthesia will be applied with a paramedian approach. Receives: Procedure: median approach; Procedure: paramedian approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
spinal needle touches the spinal bone
The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
Measured: 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.
Measured: 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.
Measured: during the procedure of spinal anesthesia
Secondary outcomes (2)
success rate of spinal needle insertion
The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.
Measured: 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
Measured: during the procedure of spinal anesthesia and 1 week after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start13 Jun 2018
- Primary completion20 Nov 2019
- Study completion22 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyfi KARTAL, MD, Trabzon Kanuni Education and Research Hospital
- Investigators
- Hülya Kılıç Yılmaz, Study chair, Trabzon Kanuni Eğitim araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750877
- Sponsor's protocol ID
- +90
- Status last verified
- Jan 2022
- First submitted
- 17 Nov 2018
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: stated that the personal data will not be shared in the participant consent form in the study design.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Median and Paramedian Approach in Spinal Anesthesia in Elderly Patients
- ClinicalTrials.gov ID
- NCT03750877
- Acronym / sponsor ID
- +90
- Conditions
- Geriatric Patients, Efficacy, Self
- Keywords
- median approach, paramedian approach, geriatric patient, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 22 Feb 2020 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| median approach | Active comparator | Procedure: median approach, Procedure: paramedian approachSpinal anesthesia will be performed with a conventional median approach |
| paramedian approach | Active comparator | Procedure: median approach, Procedure: paramedian approachSpinal anesthesia will be applied with a paramedian approach. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| median approachAlso: classical approachspinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line. | Procedure or surgery | median approach, paramedian approach |
| paramedian approachIn spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area. | Procedure or surgery | median approach, paramedian approach |
Primary outcome
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.
2 secondary outcomes
success rate of spinal needle insertion
Time frame: during the procedure of spinal anesthesia
Complications of the procedure
Time frame: during the procedure of spinal anesthesia and 1 week after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- 'Comparison of Epidrum, Epi-jet, and Loss of Resistance Syringe Techniques for Identifying the Epidural Space in Obstetric Patients'Link provided by the sponsor.
- 'Paramedian technique of spinal anesthesia in elderly patients for hip fracture surgery'.Link provided by the sponsor.
- Individual participant dataSharing planned: No. stated that the personal data will not be shared in the participant consent form in the study design.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hülya Kılıç Yılmaz study chair
Trabzon Kanuni Eğitim araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing median approach and paramedian approach in people with Geriatric Patients and Efficacy, Self, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spinal needle touches the spinal bone (time frame: during the procedure of spinal anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.