Clinical trial NCT06375057: Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
Official title: Relationship Between Acute Phase Markers and Acute Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative Pain
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes patients undergoing laparoscopic cholecystectomy

Brief summary: Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.

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.

Detailed description: The day after surgery, some serum markers are determined by a blood sample.

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.

Eligibility criteria: Inclusion Criteria:

* patient undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* children

Primary outcomes:
measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy
timeFrame: one day
measure: Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy
timeFrame: one day
measure: Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy
timeFrame: one day
measure: Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy
timeFrame: one day
measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Augusto Lauro
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.