- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558553
Are Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, and Systemic Immune Inflammation Score Values Indicators for Postoperative Pain?
Study Overview
Status
Detailed Description
Subject Researched:
Postoperative pain is a result of the inflammatory response to surgical trauma. Local inflammatory mediator response triggered by surgical incision, dissection, retraction, etc. causes an increase in nociceptor sensitivity and hyperalgesia, resulting in the perception of postoperative pain. With the acute phase response caused by surgical trauma, tissue damage is brought under control, infection is limited and the healing process begins. During the inflammatory response, the level of leukocytes in the blood also changes. Neutrophil/Lymphocyte ratio (NLR), Platelet/Lymphocyte ratio (PLR) and Systemic immune inflammation score (SII) are inexpensive and easily accessible biomarkers calculated from routine hemogram parameters and shown to be helpful in disease investigations and evaluation of treatment response. In this study, the relationship between biomarkers and postoperative pain status due to surgery will be investigated
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Samsun, Turkey
- Samsun University
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Samsun, Turkey
- Samsun University Samsun Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18-75 years who underwent elective laparoscopic cholecystectomy.
- Patients with ASA status1-2-3
Exclusion Criteria:
- Emergency operated patients
- Patients switched to open surgery
- Patients allergic to tramadol
- Those allergic to paracetamol
- Those allergic to tenoxicam
- Patients who cannot use the patient-controlled analgesia device
- Those with hematological disorders
- Those receiving immunosuppressive therapy
- Those with inflammatory disease
- Those with gastrointestinal tumors
- Those with rheumatic disease
- Those with uncontrolled diabetes
- Those with chronic organ failure
- Those who use corticosteroids
- Opioid users
- Those who have recently had an attack of cholecystitis, pancreatitis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative analgesic consumption
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain score
Time Frame: 24 hours
|
NRS 0-10 point
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şenay Canikli Adıgüzel, responsibl investigator
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/4/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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