Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
NCT ID: NCT06375057
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
54 participants
OBSERVATIONAL
2023-03-03
2025-12-31
Brief Summary
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The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:
* predict the severity of pain;
* select most suitable pain relief therapy for the patient.
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Detailed Description
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The markers analyzed are:
* Leukocytes;
* C-reactive protein (CRP);
* D-dimer;
* Fibrinogen;
* Neutrophil-to-Lymphocyte Ratio (NLR).
Pain level is assessed using the NRS scale at different times:
* 1st post-operative day;
* 7th post-operative day;
* One month after surgery;
* Three months after surgery;
* Six months after surgery.
Other data collected for the study are: gender, age, BMI.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients undergoing laparoscopic cholecystectomy
laparoscopic cholecystectomy
A blood sample is taken the day after surgery
Interventions
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laparoscopic cholecystectomy
A blood sample is taken the day after surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Augusto Lauro
Associate professor
Locations
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Augusto Lauro
Roma, , Italy
Countries
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Central Contacts
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Lauro
Role: CONTACT
Facility Contacts
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References
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Rathee A, Chaurasia MK, Singh MK, Singh V, Kaushal D. Relationship Between Pre- and Post-Operative C-Reactive Protein (CRP), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR) With Post-Operative Pain After Total Hip and Knee Arthroplasty: An Observational Study. Cureus. 2023 Aug 20;15(8):e43782. doi: 10.7759/cureus.43782. eCollection 2023 Aug.
Shu B, Xu F, Zheng X, Zhang Y, Liu Q, Li S, Chen J, Chen Y, Huang H, Duan G. Change in perioperative neutrophil-lymphocyte ratio as a potential predictive biomarker for chronic postsurgical pain and quality of life: an ambispective observational cohort study. Front Immunol. 2023 Apr 12;14:1177285. doi: 10.3389/fimmu.2023.1177285. eCollection 2023.
Gonzalez-Callejas C, Aparicio VA, De Teresa C, Nestares T. Association of Body Mass Index and Serum Markers of Tissue Damage with Postoperative Pain. The Role of Lactate Dehydrogenase for Postoperative Pain Prediction. Pain Med. 2020 Aug 1;21(8):1636-1643. doi: 10.1093/pm/pnz325.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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asiamkfv49wurfpylld2m6g7cr4kz6
Identifier Type: -
Identifier Source: org_study_id
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