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

Recruiting

• Conditions: Post Operative Pain
• Interventions: Procedure: laparoscopic cholecystectomy

• Registration Number: NCT06375057
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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 Timeline

• Study Start: 2023-03-03
• Primary Completion: 2024-02-26
• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• patient undergoing laparoscopic cholecystectomy

Exclusion Criteria

• children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergoing laparoscopic cholecystectomy	laparoscopic cholecystectomy	-

Primary Outcome Measures

Name	Time	Method
Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy	one day	The study compares post-operative pain, measured with the NRS scale, with white blood cell count (x 10\^9/L) 24 hours after surgery
Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy	one day	The study compares post-operative pain, measured with the NRS scale, with CRP (µg/L) levels 24 hours after surgery
Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy	one day	The study compares post-operative pain, measured with the NRS scale, with D-dimer (µg/L FEU) levels 24 hours after surgery
Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy	one day	The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery
Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy	one day	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.

Trial Locations

Locations (1)

Augusto Lauro; 🇮🇹 Roma, Italy