- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209958
The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
January 22, 2022 updated by: Ersagun Tugcugil, Karadeniz Technical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trabzon, Turkey
- KaradenızTU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- Patient graded as American Society of Anesthesiologist (ASA) physical status, I, II or III
- Patient subjected to thoracotomy operation
Exclusion Criteria:
Patient having morbid obesity,
- Patient having renal failure,
- Patient having hepatic failure,
- Patient having neuropsychiatric disease,
- Patient allergy to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Patients with NLR level below 2
|
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).
|
|
Group B
Patients with NLR level equal to or above 2
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
preoperative neutrophil lymphoycte ratio
Time Frame: 24 hours before the operation
|
To determine the epidural application with preoperative neutrophil lymphoycte ratio
|
24 hours before the operation
|
|
Postoperative opioid requiremen Postoperative opioid requirement
Time Frame: postoperative first 24 hour
|
Postoperative opioid requirement for pain relief
|
postoperative first 24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale
Time Frame: postoperative first 24 hour
|
Numerical Pain Rating Scale in postoperative period
|
postoperative first 24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2020
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
January 10, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 22, 2022
First Posted (Actual)
January 27, 2022
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 22, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2020/66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neutrophil Lynphosite ratio
-
Zekai Tahir Burak Women's Health Research and Education...UnknownEclampsia | PreeclampsiaTurkey
-
Assiut UniversityCompletedCopd | COPD ExacerbationEgypt
-
Sohag UniversityNot yet recruiting
-
Assiut UniversityCompleted
-
Clinica Universitaria Reina Fabiola, Universidad...CompletedAcute DiverticulitisArgentina
-
Firat ErginCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedBacterial InfectionsFrance
-
Tepecik Training and Research HospitalCompletedNeural Tube Defects | Newborn Sepsis
-
Ain Shams UniversityUnknown
-
Assiut UniversityRecruiting