Knee OsteoarthritisPhase 4NCT06233630
Erector Spinae Plane Block Vs. IPACK Block with Adductor Canal Block for Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine 0.2% Injectable Solution ESPB and Ropivacaine 0.2% Injectable Solution iPACK+ACB 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 Erector Spinae Plane Block and iPACK block with Adductor Canal Block 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 Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- What is being tested?
- Ropivacaine 0.2% Injectable Solution ESPB and Ropivacaine 0.2% Injectable Solution iPACK+ACB
- Type of treatment
- Pill or oral medicine, 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
- 30 Mar 2024to 20 Aug 2024
- 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 20-100 years,
- 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
- do not accept the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty
Read the detailed description
Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory 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 emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Being tested
- Control Test - spinal anesthesia, Ropivacaine 0.2% Injectable Solution ESPB, Ropivacaine 0.2% Injectable Solution iPACK+ACB
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Test - spinal anesthesiaDrug
Also called spinal anesthesia
No peripheral nerve block Only spinal anesthesia
Ropivacaine 0.2% Injectable Solution ESPBDrug
Also called erector spinae plane block
ultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral
Ropivacaine 0.2% Injectable Solution iPACK+ACBDrug
Also called iPACK+ACB
ultrasound guided iPACK block + Adductor Canal Block
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Only spinal anaesthesia - No peripheral nerve block Receives: Drug: Control Test - spinal anesthesia |
| Erector Spinae Plane Block | Active comparator | spinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution ESPB |
| Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block | Active comparator | spinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine
+ ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine Receives: Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACB |
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
Secondary outcomes (10)
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours
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: 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: 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: 24 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 24 hours postoperatively
PLR
Platelet-to-lymphocyte ratio
Measured: 24 hours postoperatively
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start30 Mar 2024
- Primary completion16 Aug 2024
- Study completion20 Aug 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, 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
- Investigators
- Malgorzata Domagalska, Ph.D., Principal investigator, Poznan University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233630
- Sponsor's protocol ID
- 4/2024
- Status last verified
- Sep 2024
- First submitted
- 22 Jan 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 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 Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06233630
- Acronym / sponsor ID
- 4/2024
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- 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
- 30 Mar 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 31 Jan 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 Erector Spinae Plane Block and iPACK block with Adductor Canal Block on pain management, and NLR and PLR following knee arthroplasty
Detailed description
Knee arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prosthesis. Regional anesthesia methods may be performed to reduce the inflammatory 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 emphasized. However, very few studies have evaluated the effect of various methods of anesthesia on the NLR.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Control Test - spinal anesthesiaOnly spinal anaesthesia - No peripheral nerve block |
| Erector Spinae Plane Block | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution ESPBspinal anaesthesia and unilateral ultrasound guided erector spinae plane block - 20ml 0.2% ropivacaine |
| Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block | Active comparator | Drug: Ropivacaine 0.2% Injectable Solution iPACK+ACBspinal anaesthesia and ultrasound guided Infiltration of local anesthetic between the Popliteal Artery and Capsule of the Knee (iPACK) block - 20ml 0.2% ropivacaine + ultrasound guided Adductor Canal Block - 10ml 0.2% ropivacaine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III,
- Aged 20-100 years,
- scheduled for knee arthroplasty under spinal anaesthesia
Key exclusion criteria (8 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),
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 |
|---|---|---|
| Control Test - spinal anesthesiaAlso: spinal anesthesiaNo peripheral nerve block Only spinal anesthesia | Drug | Placebo |
| Ropivacaine 0.2% Injectable Solution ESPBAlso: erector spinae plane blockultrasound guided erector spinae plane block (ESPB) - L2 level, unilateral | Drug | Erector Spinae Plane Block |
| Ropivacaine 0.2% Injectable Solution iPACK+ACBAlso: iPACK+ACBultrasound guided iPACK block + Adductor Canal Block | Drug | Infiltration Popliteal Artery and Capsule of the Knee and Adductor Canal Block |
Primary outcome
Opioid consumption
Time frame: 48 hours
Total opiate consumption after surgery
10 secondary outcomes
first need of opiate
Time frame: 48 hours
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: 16 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 20 hours after surgery
Numerical Rating Scale [range 0:10]
Time frame: 24 hours after surgery
NLR
Time frame: 24 hours postoperatively
PLR
Time frame: 24 hours postoperatively
Quadriceps muscle strength assessed using medical research council scale [range 0:5]
Time frame: 24 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 26 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 Domagalska, Ph.D. principal investigator
Poznan University of Medical Science
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 ESPB and Ropivacaine 0.2% Injectable Solution iPACK+ACB 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 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: finished, as of the sponsor's last update on 26 Sep 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?
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?
Opioid consumption (time frame: 48 hours). 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 26 Sep 2024.