Inguinal HerniaNCT05058378
Correlation Between Spinal Anesthesia and Perfusion Index
An observational study of Inguinal Hernia, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
Investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- perfusion index measurement
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 1 Feb 2022
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients between the ages of 18-65
Who may be able to join
- Patients who will undergo lower abdominal, urogenital, lower extremity surgery
- Patients with ASA 1-2
- Patients aged 18-65
Who cannot join
- Patients with ASA3-4
- Those with peripheral vascular disease
- Patients with a history of by-pass
- Patients with aortic stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adıyaman University
Adıyaman
öznur uludağ, 05052309730 ext. +9 04162231690, uludagoznur@gmail.com
About this study
Official title: Investigation of the Correlation Between the Success of Obtaining Unilateral Spinal Anesthesia and the Measurement of Perfusion Index (pi).
Investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi).
Read the detailed description
Target sites for spinal anesthetics are spinal nerve roots and spinal cord. Differences in the anatomy of the nerve roots may explain the variability that occurs during spinal anesthesia. Spinal anesthesia is the cessation of nerve conduction for a while by injection of local anesthetic drug into the cerebrospinal fluid. It is one of the most effective and oldest regional anesthesia techniques. Unilateral spinal anesthesia, on the other hand, aims to limit the distribution of the spinal block to the operated side for all operations involving only one lower extremity. Reducing the dose of local anesthetic, pencil-point needles, injection speed, lateral decubitus position and non-isobaric anesthetic solution are the main factors in the formation of a unilateral spinal block. It requires slightly longer preparation time compared to standard spinal anesthesia, but provides fewer hemodynamic side effects with higher cardiovascular stability, increased postoperative autonomy and better patient acceptance. Perfusion index (PI) is a numerical value showing the ratio between pulsatile and nonpulsatile blood flow. PI works by measuring changes in finger peripheral perfusion via pulse oximetry. If the procedure is successful in patients undergoing spinal anesthesia, vasodilation occurs in the lower extremities due to sympathetic nerve blockage and perfusion increases. Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.
- Conditions
- Inguinal Hernia
- Being tested
- perfusion index measurement
- Keywords
- spinal anesthesia, perfusion index
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion index measurementDevice
Clip will be attached to the patient's toe for perfusion index measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index is my indicator of unilateral spinal anesthesia
Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start20 Sep 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEHMET DURAN, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058378
- Sponsor's protocol ID
- date:22/12/2020 ID:2020/11-20
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation Between the Success of Obtaining Unilateral Spinal Anesthesia and the Measurement of Perfusion Index (pi).
- ClinicalTrials.gov ID
- NCT05058378
- Acronym / sponsor ID
- date:22/12/2020 ID:2020/11-20
- Conditions
- Inguinal Hernia
- Keywords
- spinal anesthesia, perfusion index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 27 Sep 2021 (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.
Investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi).
Detailed description
Target sites for spinal anesthetics are spinal nerve roots and spinal cord. Differences in the anatomy of the nerve roots may explain the variability that occurs during spinal anesthesia. Spinal anesthesia is the cessation of nerve conduction for a while by injection of local anesthetic drug into the cerebrospinal fluid. It is one of the most effective and oldest regional anesthesia techniques. Unilateral spinal anesthesia, on the other hand, aims to limit the distribution of the spinal block to the operated side for all operations involving only one lower extremity. Reducing the dose of local anesthetic, pencil-point needles, injection speed, lateral decubitus position and non-isobaric anesthetic solution are the main factors in the formation of a unilateral spinal block. It requires slightly longer preparation time compared to standard spinal anesthesia, but provides fewer hemodynamic side effects with higher cardiovascular stability, increased postoperative autonomy and better patient acceptance. Perfusion index (PI) is a numerical value showing the ratio between pulsatile and nonpulsatile blood flow. PI works by measuring changes in finger peripheral perfusion via pulse oximetry. If the procedure is successful in patients undergoing spinal anesthesia, vasodilation occurs in the lower extremities due to sympathetic nerve blockage and perfusion increases. Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients between the ages of 18-65
Key inclusion criteria (3 listed)
- Patients who will undergo lower abdominal, urogenital, lower extremity surgery
- Patients with ASA 1-2
- Patients aged 18-65
Key exclusion criteria (4 listed)
- Patients with ASA3-4
- Those with peripheral vascular disease
- Patients with a history of by-pass
- Patients with aortic stenosis
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 |
|---|---|---|
| perfusion index measurementClip will be attached to the patient's toe for perfusion index measurement | Device | – |
Primary outcome
perfusion index is my indicator of unilateral spinal anesthesia
Time frame: 1 month
Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No. I do not plan to make individual participant data available to other researchers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Adiyaman University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact öznur uludağ (05052309730 ext. +904162231690, uludagoznur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perfusion index is my indicator of unilateral spinal anesthesia (time frame: 1 month). 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 Sep 2021.