Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study

Recruiting

• Conditions: Post Operative Pain; Inguinal Hernia
• Interventions: Procedure: Open Tension-free Inguinal Hernia Repair

• Registration Number: NCT06380140
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Many patients undergoing inguinal hernia repair 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: 2023-05-03
• Primary Completion: 2024-03-03
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• patient undergoing Open Tension-free Inguinal Hernia Repair

Exclusion Criteria

• children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergoing Open Tension-free Inguinal Hernia Repair	Open Tension-free Inguinal Hernia Repair	-

Primary Outcome Measures

Name	Time	Method
Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair	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 Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair	one day	The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery
Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair	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 Open Tension-free Inguinal Hernia Repair	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 white blood cell count in Open Tension-free Inguinal Hernia Repair	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

Trial Locations

Locations (1)

Augusto Lauro; 🇮🇹 Roma, Italy