Knee OsteoarthritisPhase 4NCT06470542
Two-level ESPB in Total Knee Arthroplasty
A Phase 4 study testing 2 x 20 ml of Ropivacaine 0.2% Injectable Solution and 2 x 20ml of Ropivacaine 0.2% Injectable Solution 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 two-level ESPB in 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?
- 2 x 20 ml of Ropivacaine 0.2% Injectable Solution and 2 x 20ml of 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
- 7 Nov 2024to 5 Aug 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: Two-level Erector Spinae vs iPack With ACB Plane Block in Total Knee Arthroplasty
Effect of two-level ESPB in 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
- 2 x 20 ml of Ropivacaine 0.2% Injectable Solution, 2 x 20ml of 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.
2 x 20 ml of Ropivacaine 0.2% Injectable SolutionDrug
Also called iPACK + ACB
2 x 20ml 0.2% Ropivacaine - ultrasound-guided iPACK + ACB
2 x 20ml of Ropivacaine 0.2% Injectable SolutionDrug
Also called Erector spinae plane block (ESPB)
2 x 20ml 0.2% ropivacaine - ultrasound-guided ESPB at the L1 and S1 level
| Study group | Role | What they receive |
|---|---|---|
| iPACK + ACB | Active comparator | Ultrasound-guided iPACK +ACB Receives: Drug: 2 x 20 ml of Ropivacaine 0.2% Injectable Solution |
| Two-Level ESPB | Active comparator | Bi-level Ultrasound-guided ESPB et the L1 and S1 Receives: Drug: 2 x 20ml of Ropivacaine 0.2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption
Total opioid consumption after surgery - within 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (14)
Time to first rescue opioid analgesia
Time after surgery when the patient needs opiate for the first time
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: 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
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: 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 (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
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 start7 Nov 2024
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT06470542
- Sponsor's protocol ID
- 9/2024
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detailed data sharing plan to be defined
Publications
Pietraszek P, Reysner T, Gola W, Kluzik A, Perek A, Marszalek-Buko J, Reysner M. Combined iPACK and adductor canal block versus two-level erector spinae plane block in elderly patients undergoing total knee arthroplasty: a randomized, triple-blinded clinical trial. Arch Orthop Trauma Surg. 2026 Mar 28;146(1):128. doi: 10.1007/s00402-026-06247-x.
PubMed 41902932
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-level Erector Spinae vs iPack With ACB Plane Block in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06470542
- Acronym / sponsor ID
- 9/2024
- 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
- 7 Nov 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 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 two-level ESPB in 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 |
|---|---|---|
| iPACK + ACB | Active comparator | Drug: 2 x 20 ml of Ropivacaine 0.2% Injectable SolutionUltrasound-guided iPACK +ACB |
| Two-Level ESPB | Active comparator | Drug: 2 x 20ml of Ropivacaine 0.2% Injectable SolutionBi-level Ultrasound-guided ESPB et the L1 and S1 |
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 |
|---|---|---|
| 2 x 20 ml of Ropivacaine 0.2% Injectable SolutionAlso: iPACK + ACB2 x 20ml 0.2% Ropivacaine - ultrasound-guided iPACK + ACB | Drug | iPACK + ACB |
| 2 x 20ml of Ropivacaine 0.2% Injectable SolutionAlso: Erector spinae plane block (ESPB)2 x 20ml 0.2% ropivacaine - ultrasound-guided ESPB at the L1 and S1 level | Drug | Two-Level ESPB |
Primary outcome
Total Opioid Consumption
Time frame: 48 hours after surgery
Total opioid consumption after surgery - within 48 hours after surgery
14 secondary outcomes
Time to first rescue opioid analgesia
Time frame: 48 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
NLR
Time frame: 24 hours after surgery
NLR
Time frame: 48 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
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 25 Nov 2025.
- Derived from this study: PubMed 41902932Pietraszek P, Reysner T, Gola W, Kluzik A, Perek A, Marszalek-Buko J, Reysner M. Combined iPACK and adductor canal block versus two-level erector spinae plane block in elderly patients undergoing total knee arthroplasty: a randomized, triple-blinded clinical trial. Arch Orthop Trauma Surg. 2026 Mar 28;146(1):128. doi: 10.1007/s00402-026-06247-x.
- Individual participant dataSharing planned: Yes. Detailed data sharing plan to be defined
Related trials for Knee Osteoarthritis
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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 2 x 20 ml of Ropivacaine 0.2% Injectable Solution and 2 x 20ml of Ropivacaine 0.2% Injectable Solution 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 25 Nov 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?
Total Opioid Consumption (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?
On the ClinicalTrials.gov record for NCT06470542, which also lists 1 linked publication.
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 25 Nov 2025.