Clinical trial NCT06380140: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study
Official title: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative Pain
Inguinal Hernia
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes patients undergoing Open Tension-free Inguinal Hernia Repair

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.

Eligibility criteria: Inclusion Criteria:

* patient undergoing Open Tension-free Inguinal Hernia Repair

Exclusion Criteria:

* children

Primary outcomes:
measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair
timeFrame: one day
measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair
timeFrame: one day
measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair
timeFrame: one day
measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair
timeFrame: one day
measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Augusto Lauro
Study officials:
References:
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