Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study

NCT06375057 | Recruiting

• 1 other identifier: asiamkfv49wurfpylld2m6g7cr4kz6
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (5)

• Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy

  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 Laparoscopic Cholecystectomy

  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 Laparoscopic Cholecystectomy

  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 Laparoscopic Cholecystectomy

  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 Laparoscopic Cholecystectomy

  The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery. NLR results from the ratio between the level of neutrophils and lymphocytes.

  one day

Study Arms (1)

patients undergoing laparoscopic cholecystectomy

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy PROCEDURE

A blood sample is taken the day after surgery

patients undergoing laparoscopic cholecystectomy

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 laparoscopic cholecystectomy

You may qualify if:

• patient undergoing laparoscopic cholecystectomy

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 (3)

• 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

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

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 11, 2024
• First Posted: April 19, 2024
• Study Start: March 3, 2023
• Primary Completion: February 26, 2024
• Study Completion: December 31, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)