Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study
NCT ID: NCT06380140
Last Updated: 2024-04-23
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
71 participants
OBSERVATIONAL
2023-05-03
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 Open Tension-free Inguinal Hernia Repair
Open Tension-free Inguinal Hernia Repair
A blood sample is taken the day after surgery
Interventions
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Open Tension-free Inguinal Hernia Repair
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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Hill AD, Banwell PE, Darzi A, Menzies-Gow N, Monson JR, Guillou PJ. Inflammatory markers following laparoscopic and open hernia repair. Surg Endosc. 1995 Jun;9(6):695-8. doi: 10.1007/BF00187942.
Kokotovic D, Burcharth J, Helgstrand F, Gogenur I. Systemic inflammatory response after hernia repair: a systematic review. Langenbecks Arch Surg. 2017 Nov;402(7):1023-1037. doi: 10.1007/s00423-017-1618-1. Epub 2017 Aug 22.
Vats M, Pandey D, Saha S, Talwar N, Saurabh G, Andley M, Kumar A. Assessment of systemic inflammatory response after total extraperitoneal repair and Lichtenstein repair for inguinal hernia. Hernia. 2017 Feb;21(1):65-71. doi: 10.1007/s10029-016-1543-1. Epub 2016 Nov 12.
Choi HR, Song IA, Oh TK, Jeon YT. Perioperative C-reactive protein is associated with pain outcomes after major laparoscopic abdominal surgery: a retrospective analysis. J Pain Res. 2019 Mar 27;12:1041-1051. doi: 10.2147/JPR.S187249. eCollection 2019.
Tarasov DA, Lychagin AV, Yavorovkiy AG, Lipina MM, Tarasova IA. C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty. Int Orthop. 2020 Sep;44(9):1727-1735. doi: 10.1007/s00264-020-04551-8. Epub 2020 Apr 16.
Esme H, Kesli R, Apiliogullari B, Duran FM, Yoldas B. Effects of flurbiprofen on CRP, TNF-alpha, IL-6, and postoperative pain of thoracotomy. Int J Med Sci. 2011 Mar 10;8(3):216-21. doi: 10.7150/ijms.8.216.
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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cami3zgmxf3vqyc30ndmdqh6gfjid1
Identifier Type: -
Identifier Source: org_study_id
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