C23.550.767.700NCT05209958
The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
An observational study of C23.550.767.700 and C23.550.470, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship of preoperative Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR level on timing of epidural analgesia in thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- C23.550.767.700, C23.550.470
- What is being tested?
- Neutrophil Lynphosite ratio
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2020to 10 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 60 female and male patients aged 18-75 years, in the ASA I-III risk group, who will undergo elective thoracotomy
Who may be able to join
- Patient graded as American Society of Anesthesiologist (ASA) physical status, I, II or III
- Patient subjected to thoracotomy operation
Who cannot join
- Patient having morbid obesity,
- Patient having renal failure,
- Patient having hepatic failure,
- Patient having neuropsychiatric disease,
- Patient allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the relationship of preoperative Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR level on timing of epidural analgesia in thoracotomy.
Read the detailed description
The study was conducted prospectively in 60 patients aged 18-75 years, ASA I-III, who underwent thoracotomy. The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28). Each group was divided into subgroups with equal numbers of Prempative analgesia group and control group. Local anesthetic was administered to the preemptive analgesia group (Group P) 20 minutes before the surgical incision through the epidural catheter, and to the control group (Group K) 20 minutes before the patient was awakened from the epidural catheter. NRS levels and additional analgesia needs were recorded at 2, 4, 8, 12 and 24 hours postoperatively.
- Conditions
- C23.550.767.700, C23.550.470
- Being tested
- Neutrophil Lynphosite ratio
- Keywords
- Preemptive Epidural Analgesia, Neutrophil/Lymphocyte Ratio, İnflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil Lynphosite ratioDiagnostic test
The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with NLR level below 2 Receives: Diagnostic Test: Neutrophil Lynphosite ratio | |
| Group B | Patients with NLR level equal to or above 2 Receives: Diagnostic Test: Neutrophil Lynphosite ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative neutrophil lymphoycte ratio
To determine the epidural application with preoperative neutrophil lymphoycte ratio
Measured: 24 hours before the operation
Postoperative opioid requiremen Postoperative opioid requirement
Postoperative opioid requirement for pain relief
Measured: postoperative first 24 hour
Secondary outcomes (1)
Numerical Pain Rating Scale
Numerical Pain Rating Scale in postoperative period
Measured: postoperative first 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Jun 2020
- Primary completion1 Sep 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C23.550.767.700Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersagun Tugcugil, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209958
- Sponsor's protocol ID
- 2020/66
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
- ClinicalTrials.gov ID
- NCT05209958
- Acronym / sponsor ID
- 2020/66
- Conditions
- C23.550.767.700, C23.550.470
- Keywords
- Preemptive Epidural Analgesia, Neutrophil/Lymphocyte Ratio, İnflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 27 Jan 2022 (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.
The aim of this study is to investigate the relationship of preoperative Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR level on timing of epidural analgesia in thoracotomy.
Detailed description
The study was conducted prospectively in 60 patients aged 18-75 years, ASA I-III, who underwent thoracotomy. The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28). Each group was divided into subgroups with equal numbers of Prempative analgesia group and control group. Local anesthetic was administered to the preemptive analgesia group (Group P) 20 minutes before the surgical incision through the epidural catheter, and to the control group (Group K) 20 minutes before the patient was awakened from the epidural catheter. NRS levels and additional analgesia needs were recorded at 2, 4, 8, 12 and 24 hours postoperatively.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Neutrophil Lynphosite ratioPatients with NLR level below 2 |
| Group B | – | Diagnostic Test: Neutrophil Lynphosite ratioPatients with NLR level equal to or above 2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 female and male patients aged 18-75 years, in the ASA I-III risk group, who will undergo elective thoracotomy
Key inclusion criteria (2 listed)
- Patient graded as American Society of Anesthesiologist (ASA) physical status, I, II or III
- Patient subjected to thoracotomy operation
Key exclusion criteria (5 listed)
- Patient having morbid obesity,
- Patient having renal failure,
- Patient having hepatic failure,
- Patient having neuropsychiatric disease,
- Patient allergy to the study drugs
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 |
|---|---|---|
| Neutrophil Lynphosite ratioThe patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28). | Diagnostic test | Group A, Group B |
Primary outcome
preoperative neutrophil lymphoycte ratio
Time frame: 24 hours before the operation
To determine the epidural application with preoperative neutrophil lymphoycte ratio
Postoperative opioid requiremen Postoperative opioid requirement
Time frame: postoperative first 24 hour
Postoperative opioid requirement for pain relief
1 secondary outcome
Numerical Pain Rating Scale
Time frame: postoperative first 24 hour
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 C23.550.767.700 and C23.550.470, run by Karadeniz Technical 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 2 inclusion and 5 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?
preoperative neutrophil lymphoycte ratio (time frame: 24 hours before the operation). The study lists 2 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.