Post Operative PainNCT06380140
Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study
An observational study of Post Operative Pain and Inguinal Hernia, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Inguinal Hernia
- What is being tested?
- Open Tension-free Inguinal Hernia Repair
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- 3 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes patients undergoing Open Tension-free Inguinal Hernia Repair
Who may be able to join
- patient undergoing Open Tension-free Inguinal Hernia Repair
Who cannot join
- children
Trial locations and contacts
1 site in 1 country.
Lauro contact
Italy1 site, 1 recruiting
- Recruiting
Augusto Lauro
Roma, 000186
Augusto Lauro, +39 388 8663 879, augusto.lauro@uniroma1.it
About this study
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.
Read the 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.
- Conditions
- Post Operative Pain, Inguinal Hernia
- Being tested
- Open Tension-free Inguinal Hernia Repair
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Tension-free Inguinal Hernia RepairProcedure or surgery
A blood sample is taken the day after surgery
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing Open Tension-free Inguinal Hernia Repair | Not described Receives: Procedure: Open Tension-free Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start3 May 2023
- Primary completion3 Mar 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Augusto Lauro, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380140
- Sponsor's protocol ID
- cami3zgmxf3vqyc30ndmdqh6gfjid1
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7482166Kokotovic 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.
PubMed 28831565Vats 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.
PubMed 27838831Choi 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.
PubMed 31114292Tarasov 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.
PubMed 32300831Esme 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.
PubMed 21448308Rathee 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.
PubMed 37731439Shu 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.
PubMed 37122722Gonzalez-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.
PubMed 31845982
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study
- ClinicalTrials.gov ID
- NCT06380140
- Acronym / sponsor ID
- cami3zgmxf3vqyc30ndmdqh6gfjid1
- Conditions
- Post Operative Pain, Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing Open Tension-free Inguinal Hernia Repair | – | Procedure: Open Tension-free Inguinal Hernia Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients undergoing Open Tension-free Inguinal Hernia Repair
Key inclusion criteria (1 listed)
- patient undergoing Open Tension-free Inguinal Hernia Repair
Key exclusion criteria (1 listed)
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Tension-free Inguinal Hernia RepairA blood sample is taken the day after surgery | Procedure or surgery | patients undergoing Open Tension-free Inguinal Hernia Repair |
Primary outcome
Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair
Time frame: one day
The study compares post-operative pain, measured with the NRS scale, with CRP (μg/L) levels 24 hours after surgery
Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair
Time frame: one day
The study compares post-operative pain, measured with the NRS scale, with D-dimer (μg/L FEU) levels 24 hours after surgery
Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair
Time frame: one day
The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery
Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair
Time frame: one day
The study compares post-operative pain, measured with the NRS scale, with white blood cell count (x 10^9/L) 24 hours after surgery
Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair
Time frame: one day
The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Background: PubMed 7482166Hill 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.
- Background: PubMed 28831565Kokotovic 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.
- Background: PubMed 27838831Vats 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.
- Background: PubMed 31114292Choi 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.
- Background: PubMed 32300831Tarasov 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.
- Background: PubMed 21448308Esme 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.
- Background: PubMed 37731439Rathee 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.
- Background: PubMed 37122722Shu 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.
- Background: PubMed 31845982Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauro contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain and Inguinal Hernia, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Augusto Lauro (+39 338 8663 879, augusto.lauro@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair (time frame: one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380140, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.