Postoperative Pain Status of Patients Who Underwent Elective Laparoscopic CholecystectomyNCT05558553
Are Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, and Systemic Immune Inflammation Score Values Indicators for Postoperative Pain?
An observational study of Postoperative Pain Status of Patients Who Underwent Elective Laparoscopic Cholecystectomy, run by Samsun University at 2 sites in Turkey (Türkiye).
Trial summary
Postoperative pain status of patients who underwent elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Status of Patients Who Underwent Elective Laparoscopic Cholecystectomy
- How many people
- 2 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Sep 2022to 24 Sep 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
- Adult, Older adult
Study population: Patients who have undergone elective laparoscopic cholecystectomy
Who may be able to join
- Patients aged 18-75 years who underwent elective laparoscopic cholecystectomy.
- Patients with ASA status1-2-3
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
SAMSUN UNIVERSITY Samsun Training and research hospital
Samsun
Samsun Üniversity
Samsun
About this study
Postoperative pain status of patients who underwent elective laparoscopic cholecystectomy.
Read the 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
- Keywords
- Laparoscopic cholecystectomy, posoperative pain, neutrophil lymphocyte ratio, platelet lymphocyte ratio, systemic immune inflammation score, tramadol consumption
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic consumption
Measured: 24 hours
Secondary outcomes (1)
postoperative pain score
NRS 0-10 point
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start18 Sep 2022
- Primary completion23 Sep 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Status of Patients Who Underwent Elective Laparoscopic CholecystectomyStudies 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
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senay Canikli, Samsun University
- Investigators
- Şenay Canikli Adıgüzel, Study director, responsibl investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558553
- Sponsor's protocol ID
- 2022/4/11
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared
Publications
Tasargol O. A Prospective Study on the Predictability of Propofol Injection Pain. Cureus. 2020 Feb 10;12(2):e6945. doi: 10.7759/cureus.6945.
PubMed 32190496
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, and Systemic Immune Inflammation Score Values Indicators for Postoperative Pain?
- ClinicalTrials.gov ID
- NCT05558553
- Acronym / sponsor ID
- 2022/4/11
- Keywords
- Laparoscopic cholecystectomy, posoperative pain, neutrophil lymphocyte ratio, platelet lymphocyte ratio, systemic immune inflammation score, tramadol consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 28 Sep 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.
Postoperative pain status of patients who underwent elective laparoscopic cholecystectomy.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone elective laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- Patients aged 18-75 years who underwent elective laparoscopic cholecystectomy.
- Patients with ASA status1-2-3
Key exclusion criteria (16 listed)
- Emergency operated patients
- Patients switched to open surgery
- Patients allergic to tramadol
- Those allergic to paracetamol
- Those allergic to tenoxicam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative analgesic consumption
Time frame: 24 hours
1 secondary outcome
postoperative pain score
Time frame: 24 hours
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 22 Nov 2023.
- Results publication: PubMed 32190496Tasargol O. A Prospective Study on the Predictability of Propofol Injection Pain. Cureus. 2020 Feb 10;12(2):e6945. doi: 10.7759/cureus.6945.
- Individual participant dataSharing planned: No. individual participant data will not be shared
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.
Şenay Canikli Adıgüzel study director
responsibl investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Status of Patients Who Underwent Elective Laparoscopic Cholecystectomy, run by Samsun University at 2 sites 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 16 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
postoperative analgesic consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558553, which also lists 1 linked publication.
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 22 Nov 2023.