Knee ArthritisPhase 4NCT06302218
ESPB vs iPACK+ACB in Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution in people with Knee Arthritis and Knee Arthropathy, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Arthritis, Knee Arthropathy, Knee Osteoarthritis
- What is being tested?
- Ropivacaine 0.2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2024to 30 Oct 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 18 to 100 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 knee arthroplasty under spinal anaesthesia.
Who cannot join
- patients who have a history of bleeding diathesis,
- take anticoagulant therapy,
- have a History of chronic pain before surgery,
- have Multiple trauma, cannot assess their pain (dementia),
- have been operated on under general anaesthesia,
- have an infection in the area and do not accept the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement
Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following 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 surgery's induced stress response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.
This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.
- Conditions
- Knee Arthritis, Knee Arthropathy, Knee Osteoarthritis, Knee Pain Chronic, Knee Disease, Knee Rheumatism
- Being tested
- Ropivacaine 0.2% Injectable Solution, control group
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called iPACK + ACB
iPACK block + Adductor Canal Block
Ropivacaine 0.2% Injectable SolutionDrug
Also called ESPB
Erector Spinae Plane Block
control groupDrug
Also called only spinal anesthesia
only spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| iPACK + ACB | Active comparator | spinal anesthesia
+ ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine) Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Erectro Spinae Plane Block | Active comparator | spinal anesthesia
+ ultrasound guided ESPBk - 20ml 0,2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Control group | Placebo comparator | Only spinal anesthesia - No peripheral nerve block Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total opiate consumption after surgery
Measured: 48 hours after surgery
Secondary outcomes (14)
Time to first rescue opiate analgesia
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours after procedure
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: Time Frame: 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: Time Frame: 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: Time Frame: 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: Time Frame: 16 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: Time Frame: 20 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: Time Frame: 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: Time Frame: 36 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: Time Frame: 48 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 24 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 48 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
Platelet-to-lymphocyte ratio
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: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies 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, 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
- Łukasz Łapaj, Ph.D., Study chair, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302218
- Sponsor's protocol ID
- 5/2024
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- 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 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06302218
- Acronym / sponsor ID
- 5/2024
- Conditions
- Knee Arthritis, Knee Arthropathy, Knee Osteoarthritis, Knee Pain Chronic, Knee Disease, Knee Rheumatism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 8 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 with Adductor Canal Block and ESPB on pain management, and NLR and PLR following 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 surgery's induced stress response, opioid consumption, and opioid-related side effects.
In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.
This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by 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, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iPACK + ACB | Active comparator | Drug: Ropivacaine 0.2% Injectable Solutionspinal anesthesia + ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine) |
| Erectro Spinae Plane Block | Active comparator | Drug: Ropivacaine 0.2% Injectable Solutionspinal anesthesia + ultrasound guided ESPBk - 20ml 0,2% ropivacaine |
| Control group | Placebo comparator | Drug: control groupOnly spinal anesthesia - No peripheral nerve block |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.
Key exclusion criteria (6 listed)
- patients who have a history of bleeding diathesis,
- take anticoagulant therapy,
- have a History of chronic pain before surgery,
- have Multiple trauma, cannot assess their pain (dementia),
- have been operated on under general anaesthesia,
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: iPACK + ACBiPACK block + Adductor Canal Block | Drug | iPACK + ACB |
| Ropivacaine 0.2% Injectable SolutionAlso: ESPBErector Spinae Plane Block | Drug | Erectro Spinae Plane Block |
| control groupAlso: only spinal anesthesiaonly spinal anesthesia | Drug | Control group |
Primary outcome
Opioid consumption
Time frame: 48 hours after surgery
Total opiate consumption after surgery
14 secondary outcomes
Time to first rescue opiate analgesia
Time frame: 48 hours after procedure
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 4 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 8 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 12 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 24 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 36 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: Time Frame: 48 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 48 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: Postoperative 24 hours period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
Łukasz Łapaj, 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 0.2% Injectable Solution in people with Knee Arthritis and Knee Arthropathy, 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Domagalska, Ph.D. (608762068, m.domagalska@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
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 8 Mar 2024.