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

NCT06380140 | Recruiting

• 1 other identifier: cami3zgmxf3vqyc30ndmdqh6gfjid1
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Inguinal Hernia

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

patients undergoing Open Tension-free Inguinal Hernia Repair

Procedure: Open Tension-free Inguinal Hernia Repair

Interventions

Open Tension-free Inguinal Hernia Repair PROCEDURE

A blood sample is taken the day after surgery

patients undergoing Open Tension-free Inguinal Hernia Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patient undergoing Open Tension-free Inguinal Hernia Repair

You may not qualify if:

• children

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Augusto Lauro

Roma, 000186, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 7482166 BACKGROUND

• 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.

  PMID: 28831565 BACKGROUND

• 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.

  PMID: 27838831 BACKGROUND

• 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.

  PMID: 31114292 BACKGROUND

• 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.

  PMID: 32300831 BACKGROUND

• 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.

  PMID: 21448308 BACKGROUND

• 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.

  PMID: 37731439 BACKGROUND

• 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.

  PMID: 37122722 BACKGROUND

• 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.

  PMID: 31845982 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Augusto Lauro

CONTACT

+39 338 8663 879; augusto.lauro@uniroma1.it

Lauro

CONTACT

+39 06 499 70684

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: May 3, 2023
• Primary Completion: March 3, 2024
• Study Completion: December 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)