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

April 18, 2024 updated by: Augusto Lauro, University of Roma La Sapienza

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lauro
  • Phone Number: +39 06 499 70684

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Study population includes patients undergoing Open Tension-free Inguinal Hernia Repair

Description

Inclusion Criteria:

  • patient undergoing Open Tension-free Inguinal Hernia Repair

Exclusion Criteria:

  • children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing Open Tension-free Inguinal Hernia Repair
Procedure: Open Tension-free Inguinal Hernia Repair
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 Open Tension-free Inguinal Hernia Repair
Time Frame: one day
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 Open Tension-free Inguinal Hernia Repair
Time Frame: one day
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 Open Tension-free Inguinal Hernia Repair
Time Frame: one day
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 Open Tension-free Inguinal Hernia Repair
Time Frame: 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
one day
Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair
Time Frame: one day
The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Actual)

March 3, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cami3zgmxf3vqyc30ndmdqh6gfjid1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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