Knee OsteoarthritisPhase 4NCT06470204
Dexamethasone for iPACK Block With ACB in Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine and Ropivacaine+Dexamethasone in people with Knee Osteoarthritis and Knee Pain Chronic, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- What is being tested?
- Ropivacaine and Ropivacaine+Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 13 Aug 2024to 30 Mar 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients scheduled for total hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Who cannot join
- inability to provide first-party consent due to cognitive impairment or a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infiltration Between the Popliteal Artery and Capsule of the Knee Block With Adductor Canal Block With Ropivacaine vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: A Randomized Controlled Trial
Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty
Read the detailed description
Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Being tested
- Ropivacaine, Ropivacaine+Dexamethasone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2ml 0.9% NaCl)
Ropivacaine+DexamethasoneDrug
Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2mg Dexamethasone)
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | iPACK Block + ACB with Ropivacaine Receives: Drug: Ropivacaine |
| Ropivacaine + Dexamethasone | Active comparator | iPACK Block + ACB with Ropivacaine + Dexamethasone Receives: Drug: Ropivacaine+Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after surgery
Secondary outcomes (17)
Total Opioid Consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Measured: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 4 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 8 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 12 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 24 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating
Measured: 48 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Measured: 12 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)
Measured: 24 hours after surgery
Nerve damage [range 0-4]
Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; 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 posted24 Jun 2024
- Study start13 Aug 2024
- Primary completion31 Jan 2025
- Study completion30 Mar 2025
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, M.D. Ph.D., Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470204
- Sponsor's protocol ID
- 7/2024
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available to eligible researchers following the trial completion
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infiltration Between the Popliteal Artery and Capsule of the Knee Block With Adductor Canal Block With Ropivacaine vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06470204
- Acronym / sponsor ID
- 7/2024
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- 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
- 13 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 24 Jun 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 adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty
Detailed description
Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.
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 |
|---|---|---|
| Ropivacaine | Active comparator | Drug: RopivacaineiPACK Block + ACB with Ropivacaine |
| Ropivacaine + Dexamethasone | Active comparator | Drug: Ropivacaine+DexamethasoneiPACK Block + ACB with Ropivacaine + 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 hip arthroplasty
- patients aged >65 and <100 years
- patients able to provide informed consent
- patients able to reliably report symptoms to the research team
Key exclusion criteria (1 listed)
- inability to provide first-party consent due to cognitive impairment or a language barrier
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 |
|---|---|---|
| RopivacaineUltrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2ml 0.9% NaCl) | Drug | Ropivacaine |
| Ropivacaine+DexamethasoneUltrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2mg Dexamethasone) | Drug | Ropivacaine + Dexamethasone |
Primary outcome
Time to first rescue opioid analgesia
Time frame: 48 hours after surgery
Time after surgery when the patient needs opiate for the first time
17 secondary outcomes
Total Opioid Consumption
Time frame: 48 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 24 hours after surgery
Numerical Rating Scale [range 0:10]
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 [range 0-4]
Time frame: 12 hours after surgery
Nerve damage [range 0-4]
Time frame: 24 hours after surgery
Nerve damage [range 0-4]
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 23 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data will be available to eligible researchers following the trial completion
Related trials for Knee Osteoarthritis
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Malgorzata Reysner, M.D. Ph.D. 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 Phase 4 study testing Ropivacaine and Ropivacaine+Dexamethasone in people with Knee Osteoarthritis 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 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: finished, as of the sponsor's last update on 23 Jul 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?
Time to first rescue opioid analgesia (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 23 Jul 2025.