Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 11:27 AM
Study NCT ID:
NCT06375057
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-03', 'size': 179155, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-16T07:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy', 'timeFrame': 'one day', 'description': 'The study compares post-operative pain, measured with the NRS scale, with CRP (µg/L) levels 24 hours after surgery'}, {'measure': 'Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy', 'timeFrame': 'one day', 'description': 'The study compares post-operative pain, measured with the NRS scale, with D-dimer (µg/L FEU) levels 24 hours after surgery'}, {'measure': 'Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy', 'timeFrame': 'one day', 'description': 'The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery'}, {'measure': 'Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy', 'timeFrame': 'one day', 'description': 'The study compares post-operative pain, measured with the NRS scale, with white blood cell count (x 10\\^9/L) 24 hours after surgery'}, {'measure': 'Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy', 'timeFrame': 'one day', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '37731439', 'type': 'BACKGROUND', '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.'}, {'pmid': '37122722', 'type': 'BACKGROUND', '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.'}, {'pmid': '31845982', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.\n\nThe aim of the study is to show a possible correlation between pain and acute phase proteins in order to:\n\n* predict the severity of pain;\n* select most suitable pain relief therapy for the patient.', 'detailedDescription': 'The day after surgery, some serum markers are determined by a blood sample.\n\nThe markers analyzed are:\n\n* Leukocytes;\n* C-reactive protein (CRP);\n* D-dimer;\n* Fibrinogen;\n* Neutrophil-to-Lymphocyte Ratio (NLR).\n\nPain level is assessed using the NRS scale at different times:\n\n* 1st post-operative day;\n* 7th post-operative day;\n* One month after surgery;\n* Three months after surgery;\n* Six months after surgery.\n\nOther data collected for the study are: gender, age, BMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population includes patients undergoing laparoscopic cholecystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* children'}, 'identificationModule': {'nctId': 'NCT06375057', 'briefTitle': 'Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Relationship Between Acute Phase Markers and Acute Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study', 'orgStudyIdInfo': {'id': 'asiamkfv49wurfpylld2m6g7cr4kz6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing laparoscopic cholecystectomy', 'interventionNames': ['Procedure: laparoscopic cholecystectomy']}], 'interventions': [{'name': 'laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'A blood sample is taken the day after surgery', 'armGroupLabels': ['patients undergoing laparoscopic cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000186', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Augusto Lauro', 'role': 'CONTACT', 'email': 'augusto.lauro@uniroma1.it', 'phone': '+39 388 8663 879'}], 'facility': 'Augusto Lauro', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Augusto Lauro', 'role': 'CONTACT', 'email': 'augusto.lauro@uniroma1.it', 'phone': '+39 338 8663 879'}, {'name': 'Lauro', 'role': 'CONTACT', 'phone': '+39 06 499 70684'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Augusto Lauro', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}