Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 11:27 AM
Study NCT ID:
NCT06375057
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
Relationship Between Acute Phase Markers and Acute Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: