Knee ArthropathyPhase 4NCT06304298
NLR and PLR Levels Following IPACK Block in Knee Arthroplasty
A Phase 4 study testing 0.9% Sodium Chloride Injection and Ropivacaine 0.2% Injectable Solution in people with Knee Arthropathy and Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of iPACK block on NLR and PLR following knee arthroplasty Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Knee Arthropathy, Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- 0.9% Sodium Chloride Injection and Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 30 Mar 2024to 10 Feb 2025
- Phase
- Phase 4
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA classification I-III
- Aged 20-90 years
- Who will be scheduled for hip arthroplasty under spinal anesthesia
Who cannot join
- Patients who have a history of bleeding diathesis
- Take anticoagulant therapy
- History of chronic pain before surgery
- Multiple trauma
- patients unable to assess their pain (dementia)
- patients operated under general anesthesia
- patients having an infection in region of the procedure
- patient who do not accept the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neutrophil-to-lymphocyte Ratio (NLR) and Platelet-to-lymphocyte Ratio (PLR) Levels Following IPACK Block in Knee Arthroplasty: a Randomized, Controlled Trial.
Effect of iPACK block on NLR and PLR following knee arthroplasty
Read the detailed description
The NLR is a sensitive indicator of inflammation confirmed in numerous studies and has a predictive and prognostic value. NLR is a cheap, simple, fast-acting, readily available stress and inflammation parameter with high sensitivity and low specificity. Dynamic changes in the NLR precede the clinical state for several hours and may alert clinicians early about the ongoing pathological process. NLR is a new promising marker of cellular immune activation, an important indicator of stress and systemic inflammation. It opens a new dimension for clinical medicine to understand better the biology of inflammation, the linkage, and antagonism between innate and adaptive immunity, and its clinical consequences for health and disease.
NLR is affected not only by surgical trauma but also by the method of anesthesia. In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, there have been very few studies evaluating the effect of various methods of anesthesia on the NLR.
This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing knee replacement surgery.
- Conditions
- Knee Arthropathy, Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- 0.9% Sodium Chloride Injection, Ropivacaine 0.2% Injectable Solution
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called Placebo
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride
Ropivacaine 0.2% Injectable SolutionDrug
Also called iPACK block
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine
| Study group | Role | What they receive |
|---|---|---|
| Sham blocks | Active comparator | iPACK block with 20ml of 0.9% sodium chloride Receives: Drug: 0.9% Sodium Chloride Injection |
| iPACK block | Active comparator | iPACK block with 20ml 0f 0.2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-lymphocyte ratio
Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.
Measured: 12 hours after surgery
Secondary outcomes (14)
PLR
Platelet-to-lymphocyte ratio
Measured: 12 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 48 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 24 hours after surgery
NLR
Neutrophile-to-lymphocyte ratio
Measured: 48 hours after surgery
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after procedure
Opioid Consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 4 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 8 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 12 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 18 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 24 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 36 hours after surgery
Pain score
NRS (Numerical Rating Scale)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Mar 2024
- Primary completion16 Jan 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Domagalska, Ph.D., Principal investigator, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304298
- Sponsor's protocol ID
- 10/2023
- Status last verified
- Mar 2025
- First submitted
- 24 May 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neutrophil-to-lymphocyte Ratio (NLR) and Platelet-to-lymphocyte Ratio (PLR) Levels Following IPACK Block in Knee Arthroplasty: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06304298
- Acronym / sponsor ID
- 10/2023
- Conditions
- Knee Arthropathy, Knee Osteoarthritis, Knee Pain Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 12 Mar 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.
Effect of iPACK block on NLR and PLR following knee arthroplasty
Detailed description
The NLR is a sensitive indicator of inflammation confirmed in numerous studies and has a predictive and prognostic value. NLR is a cheap, simple, fast-acting, readily available stress and inflammation parameter with high sensitivity and low specificity. Dynamic changes in the NLR precede the clinical state for several hours and may alert clinicians early about the ongoing pathological process. NLR is a new promising marker of cellular immune activation, an important indicator of stress and systemic inflammation. It opens a new dimension for clinical medicine to understand better the biology of inflammation, the linkage, and antagonism between innate and adaptive immunity, and its clinical consequences for health and disease.
NLR is affected not only by surgical trauma but also by the method of anesthesia. In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, there have been very few studies evaluating the effect of various methods of anesthesia on the NLR.
This is the first study to investigate the effect of regional anesthesia on the NLR and PLR in patients undergoing knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham blocks | Active comparator | Drug: 0.9% Sodium Chloride InjectioniPACK block with 20ml of 0.9% sodium chloride |
| iPACK block | Active comparator | Drug: Ropivacaine 0.2% Injectable SolutioniPACK block with 20ml 0f 0.2% ropivacaine |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III
- Aged 20-90 years
- Who will be scheduled for hip arthroplasty under spinal anesthesia
Key exclusion criteria (8 listed)
- Patients who have a history of bleeding diathesis
- Take anticoagulant therapy
- History of chronic pain before surgery
- Multiple trauma
- patients unable to assess their pain (dementia)
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 |
|---|---|---|
| 0.9% Sodium Chloride InjectionAlso: PlaceboAfter spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride | Drug | Sham blocks |
| Ropivacaine 0.2% Injectable SolutionAlso: iPACK blockAfter spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacine | Drug | iPACK block |
Primary outcome
Neutrophil-to-lymphocyte ratio
Time frame: 12 hours after surgery
Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.
14 secondary outcomes
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
Time frame: 48 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
first need of opiate
Time frame: 48 hours after procedure
Opioid Consumption
Time frame: 48 hours after surgery
Pain score
Time frame: 4 hours after surgery
Pain score
Time frame: 8 hours after surgery
Pain score
Time frame: 12 hours after surgery
Pain score
Time frame: 18 hours after surgery
Pain score
Time frame: 24 hours after surgery
Pain score
Time frame: 36 hours after surgery
Pain score
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Knee Arthropathy
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Małgorzata Domagalska, Ph.D. principal investigator
Poznań University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.9% Sodium Chloride Injection and Ropivacaine 0.2% Injectable Solution in people with Knee Arthropathy and Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 24 Mar 2025. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-to-lymphocyte ratio (time frame: 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.