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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-03

Study Completion Date

2025-12-31

Brief Summary

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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:

* predict the severity of pain;
* select most suitable pain relief therapy for the patient.

Detailed Description

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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.

Conditions

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Post Operative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients undergoing laparoscopic cholecystectomy

laparoscopic cholecystectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patient undergoing laparoscopic cholecystectomy

Exclusion Criteria

* children
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Augusto Lauro

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Augusto Lauro

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Augusto Lauro

Role: CONTACT

+39 338 8663 879

Lauro

Role: CONTACT

+39 06 499 70684

Facility Contacts

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Augusto Lauro

Role: primary

+39 388 8663 879

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.

Reference Type BACKGROUND
PMID: 37731439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37122722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31845982 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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asiamkfv49wurfpylld2m6g7cr4kz6

Identifier Type: -

Identifier Source: org_study_id

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