Knee OsteoarthritisNCT07449442
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
A study testing sodium Chloride and Ropivacaine Hydrocloride in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- sodium Chloride and Ropivacaine Hydrocloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with ASA classification I-III
- Aged 65-100 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 the region of the procedure
- the patient who does not accept the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: iPACK Block With Adductor Canal Block Mitigates Surgical Stress and Enhances Analgesia in Total Knee Arthroplasty: A Randomized Controlled Trial
This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.
Read the detailed description
Surgical trauma induces a systemic inflammatory response characterized by neutrophilia, lymphopenia, and platelet activation. These hematologic alterations reflect the interaction between innate immune activation, stress-induced immunosuppression, and pro-thrombotic mechanisms. The modulation of this response may influence postoperative recovery and complication risk.
The Systemic Immune-Inflammation Index (SII) is calculated using the formula:
SII = (Platelet count × Neutrophil count) / Lymphocyte count SII integrates three components of systemic inflammation and immune regulation and is considered a more comprehensive marker than isolated ratios such as neutrophil-to-lymphocyte ratio (NLR) or platelet-to-lymphocyte ratio (PLR). Compared with NLR and PLR, SII may better reflect the balance between inflammatory activation and adaptive immune suppression in the perioperative period.
Regional anesthesia techniques may attenuate surgical stress by reducing afferent nociceptive signaling, sympathetic activation, and subsequent activation of the inflammatory cascade. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of the iPACK block with Adductor Canal Block on SII in hip arthroplasty has not been previously investigated.
The primary objective of this study is to determine whether the iPACK block with ACB reduces postoperative SII levels compared with the sham block in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
Peripheral venous blood samples will be collected preoperatively and at predefined postoperative time points (e.g., 12, 24, and 48 hours). The primary endpoint will be postoperative SII at 24 hours or the change from baseline (ΔSII), depending on statistical analysis plan.
This study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.
- Conditions
- Knee Osteoarthritis
- Being tested
- sodium Chloride, Ropivacaine Hydrocloride
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium ChlorideDrug
Also called 0.9% NaCl
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride; and Adductor Canal Block will be performed with 20ml of 0.9% sodium chloride
Ropivacaine HydroclorideDrug
Also called 0.2% ropivacaine
After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacaine, and the Adductor Canal Block will be performed with 20ml of 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Sham blocks | Placebo comparator | iPACK block with 20ml of 0.9% sodium chloride and ACB with 20ml of 0.9% sodium chloride Receives: Drug: sodium Chloride |
| iPACK block with ACB | Active comparator | iPACK block with 20ml of 0.2% ropivacaine and ACB with 20ml of 0.2% ropivacaine Receives: Drug: Ropivacaine Hydrocloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 12 hours after surgery
Secondary outcomes (18)
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated as:
AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
Measured: 12 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated as:
AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
Measured: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Aggregate Index of Systemic Inflammation (AISI) is calculated as:
AISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.
Measured: 48 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:
PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Measured: 12 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:
PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Measured: 24 hours after surgery
Platelet Mass Index (PMI)
Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:
PMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.
Measured: 48 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.
CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.
Higher CRP values indicate greater postoperative inflammatory response.
Measured: 12 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.
CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.
Higher CRP values indicate greater postoperative inflammatory response.
Measured: 24 hours after surgery
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.
CRP concentration is expressed in mg/L and determined using standard hospital laboratory methods.
Higher CRP values indicate greater postoperative inflammatory response.
Measured: 48 hours after surgery
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:
0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
Measured: 4 hours after surgery
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:
0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
Measured: 8 hours after surgery
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:
0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
Measured: 12 hours after surgery
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:
0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
Measured: 24 hours after surgery
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:
0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.
Measured: 48 hours after surgery
Opioid Consumption
Total opioid consumption within the first 48 hours after surgery will be recorded.
All administered opioids will be converted to intravenous morphine milligram equivalents (MME) for standardization.
Higher cumulative MME indicates greater analgesic requirement.
Measured: 48 hours after surgery
Time to First Rescue Analgesia
Time from completion of surgery to first administration of rescue opioid analgesia.
Measured in minutes. Shorter time indicates earlier breakthrough pain.
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 posted4 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449442
- Sponsor's protocol ID
- 81/26
- Status last verified
- Nov 2026
- First submitted
- 27 Feb 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPACK Block With Adductor Canal Block Mitigates Surgical Stress and Enhances Analgesia in Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07449442
- Acronym / sponsor ID
- 81/26
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Mar 2026 (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.
This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.
Detailed description
Surgical trauma induces a systemic inflammatory response characterized by neutrophilia, lymphopenia, and platelet activation. These hematologic alterations reflect the interaction between innate immune activation, stress-induced immunosuppression, and pro-thrombotic mechanisms. The modulation of this response may influence postoperative recovery and complication risk.
The Systemic Immune-Inflammation Index (SII) is calculated using the formula:
SII = (Platelet count × Neutrophil count) / Lymphocyte count SII integrates three components of systemic inflammation and immune regulation and is considered a more comprehensive marker than isolated ratios such as neutrophil-to-lymphocyte ratio (NLR) or platelet-to-lymphocyte ratio (PLR). Compared with NLR and PLR, SII may better reflect the balance between inflammatory activation and adaptive immune suppression in the perioperative period.
Regional anesthesia techniques may attenuate surgical stress by reducing afferent nociceptive signaling, sympathetic activation, and subsequent activation of the inflammatory cascade. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of the iPACK block with Adductor Canal Block on SII in hip arthroplasty has not been previously investigated.
The primary objective of this study is to determine whether the iPACK block with ACB reduces postoperative SII levels compared with the sham block in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
Peripheral venous blood samples will be collected preoperatively and at predefined postoperative time points (e.g., 12, 24, and 48 hours). The primary endpoint will be postoperative SII at 24 hours or the change from baseline (ΔSII), depending on statistical analysis plan.
This study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham blocks | Placebo comparator | Drug: sodium ChlorideiPACK block with 20ml of 0.9% sodium chloride and ACB with 20ml of 0.9% sodium chloride |
| iPACK block with ACB | Active comparator | Drug: Ropivacaine HydroclorideiPACK block with 20ml of 0.2% ropivacaine and ACB with 20ml of 0.2% ropivacaine |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III
- Aged 65-100 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 |
|---|---|---|
| sodium ChlorideAlso: 0.9% NaClAfter spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride; and Adductor Canal Block will be performed with 20ml of 0.9% sodium chloride | Drug | Sham blocks |
| Ropivacaine HydroclorideAlso: 0.2% ropivacaineAfter spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacaine, and the Adductor Canal Block will be performed with 20ml of 0.2% ropivacaine | Drug | iPACK block with ACB |
Primary outcome
Systemic Inflammation Response Index (SIRI)
Time frame: 12 hours after surgery
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula: SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L. SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
18 secondary outcomes
Systemic Inflammation Response Index (SIRI)
Time frame: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Time frame: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 12 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Time frame: 48 hours after surgery
Platelet Mass Index (PMI)
Time frame: 12 hours after surgery
Platelet Mass Index (PMI)
Time frame: 24 hours after surgery
Platelet Mass Index (PMI)
Time frame: 48 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 12 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 24 hours after surgery
C-reactive Protein (CRP) Concentration
Time frame: 48 hours after surgery
Postoperative Pain Intensity (NRS)
Time frame: 4 hours after surgery
Postoperative Pain Intensity (NRS)
Time frame: 8 hours after surgery
Postoperative Pain Intensity (NRS)
Time frame: 12 hours after surgery
Postoperative Pain Intensity (NRS)
Time frame: 24 hours after surgery
Postoperative Pain Intensity (NRS)
Time frame: 48 hours after surgery
Opioid Consumption
Time frame: 48 hours after surgery
Time to First Rescue Analgesia
Time frame: 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Malgorzata Reysner, MD PhD study chair
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 study testing sodium Chloride and Ropivacaine Hydrocloride in people with 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Reysner, MD PhD (+48 501 056 924, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Inflammation Response Index (SIRI) (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 5 Nov 2026.