Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study

Relationship Between Acute Phase Markers and Acute Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

• Study Contact: Name: Augusto Lauro; Phone Number: +39 338 8663 879; Email: augusto.lauro@uniroma1.it
• Study Contact Backup: Name: Lauro; Phone Number: +39 06 499 70684

Study Locations

• Italy
  • Roma, Italy, 000186
    • Recruiting
    • Augusto Lauro
    • Contact: Augusto Lauro; Phone Number: +39 388 8663 879; Email: augusto.lauro@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population includes patients undergoing laparoscopic cholecystectomy

Description

Inclusion Criteria:

• patient undergoing laparoscopic cholecystectomy

Exclusion Criteria:

• children

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients undergoing laparoscopic cholecystectomy	Procedure: laparoscopic cholecystectomy; A blood sample is taken the day after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: asiamkfv49wurfpylld2m6g7cr4kz6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No