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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380140
• Other study ID #: cami3zgmxf3vqyc30ndmdqh6gfjid1
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Roma La Sapienza
• Contact: Augusto Lauro
• Phone: +39 338 8663 879
• Email: augusto.lauro[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: December 31, 2025
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing Open Tension-free Inguinal Hernia Repair

Exclusion Criteria:

• children

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Open Tension-free Inguinal Hernia Repair
A blood sample is taken the day after surgery

Locations

Country	Name	City	State
Italy	Augusto Lauro	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Choi HR, Song IA, Oh TK, Jeon YT. Perioperative C-reactive protein is associated with pain outcomes after major laparoscopic abdominal surgery: a retrospective analysis. J Pain Res. 2019 Mar 27;12:1041-1051. doi: 10.2147/JPR.S187249. eCollection 2019. — View Citation

Esme H, Kesli R, Apiliogullari B, Duran FM, Yoldas B. Effects of flurbiprofen on CRP, TNF-alpha, IL-6, and postoperative pain of thoracotomy. Int J Med Sci. 2011 Mar 10;8(3):216-21. doi: 10.7150/ijms.8.216. — View Citation

Gonzalez-Callejas C, Aparicio VA, De Teresa C, Nestares T. Association of Body Mass Index and Serum Markers of Tissue Damage with Postoperative Pain. The Role of Lactate Dehydrogenase for Postoperative Pain Prediction. Pain Med. 2020 Aug 1;21(8):1636-1643. doi: 10.1093/pm/pnz325. — View Citation

Hill AD, Banwell PE, Darzi A, Menzies-Gow N, Monson JR, Guillou PJ. Inflammatory markers following laparoscopic and open hernia repair. Surg Endosc. 1995 Jun;9(6):695-8. doi: 10.1007/BF00187942. — View Citation

Kokotovic D, Burcharth J, Helgstrand F, Gogenur I. Systemic inflammatory response after hernia repair: a systematic review. Langenbecks Arch Surg. 2017 Nov;402(7):1023-1037. doi: 10.1007/s00423-017-1618-1. Epub 2017 Aug 22. — View Citation

Rathee A, Chaurasia MK, Singh MK, Singh V, Kaushal D. Relationship Between Pre- and Post-Operative C-Reactive Protein (CRP), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR) With Post-Operative Pain After Total Hip and Knee Arthroplasty: An Observational Study. Cureus. 2023 Aug 20;15(8):e43782. doi: 10.7759/cureus.43782. eCollection 2023 Aug. — View Citation

Shu B, Xu F, Zheng X, Zhang Y, Liu Q, Li S, Chen J, Chen Y, Huang H, Duan G. Change in perioperative neutrophil-lymphocyte ratio as a potential predictive biomarker for chronic postsurgical pain and quality of life: an ambispective observational cohort study. Front Immunol. 2023 Apr 12;14:1177285. doi: 10.3389/fimmu.2023.1177285. eCollection 2023. — View Citation

Tarasov DA, Lychagin AV, Yavorovkiy AG, Lipina MM, Tarasova IA. C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty. Int Orthop. 2020 Sep;44(9):1727-1735. doi: 10.1007/s00264-020-04551-8. Epub 2020 Apr 16. — View Citation

Vats M, Pandey D, Saha S, Talwar N, Saurabh G, Andley M, Kumar A. Assessment of systemic inflammatory response after total extraperitoneal repair and Lichtenstein repair for inguinal hernia. Hernia. 2017 Feb;21(1):65-71. doi: 10.1007/s10029-016-1543-1. Epub 2016 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair	The study compares post-operative pain, measured with the NRS scale, with CRP (µg/L) levels 24 hours after surgery	one day
Primary	Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair	The study compares post-operative pain, measured with the NRS scale, with D-dimer (µg/L FEU) levels 24 hours after surgery	one day
Primary	Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair	The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery	one day
Primary	Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair	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
Primary	Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair	The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery	one day