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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:
The day after surgery, some serum markers are determined by a blood sample.
The markers analyzed are:
Pain level is assessed using the NRS scale at different times:
Other data collected for the study are: gender, age, BMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing laparoscopic cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic cholecystectomy | Procedure | A blood sample is taken the day after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy | The study compares post-operative pain, measured with the NRS scale, with CRP (µg/L) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy | The study compares post-operative pain, measured with the NRS scale, with D-dimer (µg/L FEU) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy | The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy | The study compares post-operative pain, measured with the NRS scale, with white blood cell count (x 10^9/L) 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy | The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery. NLR results from the ratio between the level of neutrophils and lymphocytes. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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Study population includes patients undergoing laparoscopic cholecystectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Augusto Lauro | Contact | +39 338 8663 879 | augusto.lauro@uniroma1.it | |
| Lauro | Contact | +39 06 499 70684 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusto Lauro | Recruiting | Roma | 000186 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37731439 | Background | 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. | |
| 37122722 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Apr 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Background |
| 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. |
| 31845982 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |