Knee OsteoarthritisPhase 4NCT06086483

Pain Management After Adductor Canal Block for Total Knee Arthroplasty

A Phase 4 study testing Ropivacaine 0.2% Injectable Solution and 0.9%sodium chloride in people with Knee Osteoarthritis and Knee Arthritis, run by Poznan University of Medical Sciences at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy
What is being tested?: Ropivacaine 0.2% Injectable Solution and 0.9%sodium chloride
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 361 participants
Where: 1 sitePoland
Study dates: 18 Jun 2020to 24 Aug 2023
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 > 18 years old undergoing unilateral total knee arthroplasty

Who cannot join

refusal to participate
< 18 yo
Chronic opioid use
localized infection

Trial locations and contacts

1 site in 1 country.

Poland1 site

Poznan University of Medical Sciences
Poznan, Poznań, 61-701

Other trials in Poland

About this study

Official title: Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.

Read the detailed description

The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

Conditions: Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy, Knee Pain Chronic
Being tested: Ropivacaine 0.2% Injectable Solution, 0.9%sodium chloride
Keywords: iPACK, Adductor Canal Block, pain management, multimodal analgesia, peripheral nerve block, knee arthroplasty
Medical subject headings: Osteoarthritis, Knee, Agnosia

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 Ropimol
20 mL 0.5% ropivacaine was injected into the PENG block
20 mL 0.5% ropivacaine was injected into the Adductor Canal block
0.9%sodium chlorideDrug
Also called normal saline
20 mL 0.9% sodium chloride was injected into the PENG block
20 mL 0.5% sodium chloride was injected into the Adductor Canal block

Study groups in NCT06086483
Study group	Role	What they receive
iPACK block+ABC block	Active comparator	Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine. Receives: Drug: Ropivacaine 0.2% Injectable Solution
Sham blocks	Active comparator	Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline. Receives: Drug: 0.9%sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

postoperative Numeric Pain Rating Scale
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 24 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 48 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 72 hours after surgery
postoperative Numeric Pain Rating Scale et rest
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 96 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 48 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 72 hours after surgery
postoperative Numeric Pain Rating Scale during active flexion
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 96 hours after surgery

Secondary outcomes (6)

Postoperative opioid consumption
milligrams of intravenous morphine equivalents
Measured: 96 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 12 hours after surgery
Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Measured: 24 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Measured: 12 hours after surgery
Platelet-to-lymphocyte ratio
Platelet-to-lymphocyte ratio
Measured: 24 hours after surgery
Time to first opioid administration
Hours to first administration of an intravenous opioid drug
Measured: 96 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202024 Aug 2023

First posted17 Oct 2023
Study start18 Jun 2020
Primary completion20 Jul 2022
Study completion24 Aug 2023

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
Model description: randomized, double-blind, placebo-controlled
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06086483
Sponsor's protocol ID: 495/2020
Status last verified: Oct 2023
First submitted: 11 Oct 2023
Last updated: 17 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data presented in this study are available on request from the corresponding author.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.
ClinicalTrials.gov ID: NCT06086483
Acronym / sponsor ID: 495/2020
Conditions: Knee Osteoarthritis, Knee Arthritis, Knee Arthropathy, Knee Pain Chronic
Keywords: iPACK, Adductor Canal Block, pain management, multimodal analgesia, peripheral nerve block, knee arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: Poznan University of Medical SciencesUniversity, hospital or other
Study start: 18 Jun 2020 (actual)
Primary completion: 20 Jul 2022 (actual)
Study completion: 24 Aug 2023 (actual)
First posted: 17 Oct 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: randomized, double-blind, placebo-controlled

Arm	Type	Receives
iPACK block+ABC block	Active comparator	Drug: Ropivacaine 0.2% Injectable SolutionPatients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.
Sham blocks	Active comparator	Drug: 0.9%sodium chloridePatients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.

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 > 18 years old undergoing unilateral total knee arthroplasty

Key exclusion criteria (4 listed)

refusal to participate
< 18 yo
Chronic opioid use
localized infection

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: Ropimol20 mL 0.5% ropivacaine was injected into the PENG block 20 mL 0.5% ropivacaine was injected into the Adductor Canal block	Drug	iPACK block+ABC block
0.9%sodium chlorideAlso: normal saline20 mL 0.9% sodium chloride was injected into the PENG block 20 mL 0.5% sodium chloride was injected into the Adductor Canal block	Drug	Sham blocks

Primary outcome

postoperative Numeric Pain Rating Scale
Time frame: 24 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Time frame: 48 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Time frame: 72 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale et rest
Time frame: 96 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Time frame: 48 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Time frame: 72 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
postoperative Numeric Pain Rating Scale during active flexion
Time frame: 96 hours after surgery
Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

6 secondary outcomes

Postoperative opioid consumption
Time frame: 96 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 12 hours after surgery
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 12 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Time to first opioid administration
Time frame: 96 hours postoperatively

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 17 Oct 2023.
Individual participant dataSharing planned: Yes. The data presented in this study are available on request from the corresponding author.

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.
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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.

Zbigniew Żaba, Ph.D. study chair

Department of Emergency Medicine Clinic

Malgorzata Domagalska, Ph.D. principal investigator

Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 17 Oct 2023. 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?

postoperative Numeric Pain Rating Scale (time frame: 24 hours after surgery). The study lists 7 primary outcomes in all. 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 NCT06086483.

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 17 Oct 2023.