Osteoarthritis, KneePhase 4NCT07180953
Impact of Dexamethasone Route on Pain and Inflammation in iPACK With ACB for Knee Arthroplasty
A Phase 4 study testing NaCl 0.9% and Dexamethasone 4mg in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards: The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Pain Chronic, Arthropathy of Knee
- What is being tested?
- NaCl 0.9% and Dexamethasone 4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 13 Sep 2025to 25 Mar 2026
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients scheduled for total knee arthroplasty
- patients aged >65 and <100 years
- patients can provide informed consent
- patients can reliably report symptoms to the research team
Who cannot join
- inability to provide first-party consent due to cognitive impairment or a
- language barrier
- infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
- American Society of Anesthesiologists (ASA) physical status of IV or higher,
- history of regular steroid medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Route of Dexamethasone Administration in iPACK and ACB for Total Knee Replacement: A Randomized Trial
"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards:
The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation.
Read more
The main questions the study aims to answer are:
Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery.
Participants will:
Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic, Arthropathy of Knee
- Being tested
- NaCl 0.9%, Dexamethasone 4mg
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0.9%Drug
iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv
Dexamethasone 4mgDrug
Also called iv Dexamethasone
iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv
Dexamethasone 4mgDrug
iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 2mg Dexamethasone) + 2ml 0.9% NaCl iv
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | iPACK block with ACB Receives: Drug: NaCl 0.9% |
| iv DEX | Active comparator | iPACK block with ACB + iv Dexamethasone Receives: Drug: Dexamethasone 4mg |
| pn DEX | Active comparator | iPACK block with ACB + perineural Dexamethasone Receives: Drug: Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time to first rescue analgesia
Measured: Time Frame: 48 hours after surgery
Secondary outcomes (23)
Total opioid consumption
Total opioid consumption (mg) converted to morphine milligram equivalents (MME)
Measured: 48 hours after surgery
NRS
umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 4 hours after surgery
NRS
umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 8 hours after surgery
NRS
umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 12 hours after surgery
NRS
umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 24 hours after surgery
NRS
umeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")
Measured: 48 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 12 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 24 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
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
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Measured: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Measured: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Measured: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Measured: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale, where higher scores indicate better muscle strength
Measured: 48 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 12 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 24 hours after surgery
Nerve damage
Nerve damage assessment will be performed using the following grading scale:
N0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome
Measured: 48 hours after surgery
glucose
blood glucose level
Measured: 12 hours after surgery
glucose
blood glucose level
Measured: 24 hours after surgery
glucose
blood glucose level
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 posted18 Sep 2025
- Study start13 Sep 2025
- Primary completion1 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180953
- Sponsor's protocol ID
- 02/20025
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Route of Dexamethasone Administration in iPACK and ACB for Total Knee Replacement: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07180953
- Acronym / sponsor ID
- 02/20025
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic, Arthropathy of Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 13 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 18 Sep 2025 (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.
"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards:
The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation.
The main questions the study aims to answer are:
Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery.
Participants will:
Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: NaCl 0.9%iPACK block with ACB |
| iv DEX | Active comparator | Drug: Dexamethasone 4mgiPACK block with ACB + iv Dexamethasone |
| pn DEX | Active comparator | Drug: Dexamethasone 4mgiPACK block with ACB + perineural Dexamethasone |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients scheduled for total knee arthroplasty
- patients aged >65 and <100 years
- patients can provide informed consent
- patients can reliably report symptoms to the research team
Key exclusion criteria (7 listed)
- inability to provide first-party consent due to cognitive impairment or a
- language barrier
- infection at the site of the regional block,
- coagulation disorders,
- immunodeficiency,
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 |
|---|---|---|
| NaCl 0.9%iPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 2ml 0.9% NaCl iv | Drug | Control |
| Dexamethasone 4mgAlso: iv DexamethasoneiPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 1ml 0.9% NaCl) + 4mg Dexamethasone iv | Drug | iv DEX |
| Dexamethasone 4mgiPACK block with Adductor Canal Block (2 x 20ml 0.2% ropivacaine + 2mg Dexamethasone) + 2ml 0.9% NaCl iv | Drug | pn DEX |
Primary outcome
Time to first rescue analgesia
Time frame: Time Frame: 48 hours after surgery
Time to first rescue analgesia
23 secondary outcomes
Total opioid consumption
Time frame: 48 hours after surgery
NRS
Time frame: 4 hours after surgery
NRS
Time frame: 8 hours after surgery
NRS
Time frame: 12 hours after surgery
NRS
Time frame: 24 hours after surgery
NRS
Time frame: 48 hours after surgery
NLR
Time frame: 12 hours after surgery
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 hours after surgery
PLR
Time frame: 12 hours after surgery
PLR
Time frame: 24 hours after surgery
PLR
Time frame: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 48 hours after surgery
Nerve damage
Time frame: 12 hours after surgery
Nerve damage
Time frame: 24 hours after surgery
Nerve damage
Time frame: 48 hours after surgery
glucose
Time frame: 12 hours after surgery
glucose
Time frame: 24 hours after surgery
glucose
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 22 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NaCl 0.9% and Dexamethasone 4mg in people with Osteoarthritis, Knee and Knee Pain Chronic, 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 4 inclusion and 7 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 22 May 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.
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?
Time to first rescue analgesia (time frame: Time Frame: 48 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 22 May 2026.