Knee ArthropathyNCT06182059
Persistent Post Surgical Pain After Total Knee Arthroplasty
A study testing continuous peripheral nerve block in people with Knee Arthropathy, run by Policlinico di Monza SpA at 1 site in Italy.
Trial summary
Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- continuous peripheral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary total knee replacement with a written informed consent
Who cannot join
- Allergy to local anesthetics or any drugs involve in the study
- Controindication to regional anesthesia
- chronic use of opioids
- BMI > 35 kg m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico di Monza SPA
Monza, Monza Brianza, 20900
Gianluca Cappelleri, MD, +390392810941, gianluca.cappelleri@hotmail.com
Gianluca Perseghin, MD, +3903928109, gianluca.perseghin@policlinicodimonza.it
About this study
Official title: Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery
Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery
Read the detailed description
Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.
- Conditions
- Knee Arthropathy
- Being tested
- continuous peripheral nerve block
- Keywords
- knee arthroplasty, acute postoperative pain, persistent post surgical pain, regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous peripheral nerve blockProcedure or surgery
continuous regional anesthesia in total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| fast track | Active comparator | continuous adductor canal block and ipack block Receives: Procedure: continuous peripheral nerve block |
| traditional | Experimental | continuous femoral nerve block and continuous sciatic block Receives: Procedure: continuous peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent post surgical pain
Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement
Measured: 0-6-month
Secondary outcomes (2)
acute postoperative pain
Numeric rating score (0-10) over 4 in POD0, POD1, POD2, POD3
Measured: 0-72 hours
Morphine requirement
total morphine administration via PCA in POD0, POD1, POD2, POD3
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start12 Jan 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico di Monza SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Cappelleri, Policlinico di Monza SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182059
- Sponsor's protocol ID
- PPSP PTG
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery
- ClinicalTrials.gov ID
- NCT06182059
- Acronym / sponsor ID
- PPSP PTG
- Conditions
- Knee Arthropathy
- Keywords
- knee arthroplasty, acute postoperative pain, persistent post surgical pain, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Policlinico di Monza SpAUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 26 Dec 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.
Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery
Detailed description
Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast track | Active comparator | Procedure: continuous peripheral nerve blockcontinuous adductor canal block and ipack block |
| traditional | Experimental | Procedure: continuous peripheral nerve blockcontinuous femoral nerve block and continuous sciatic block |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary total knee replacement with a written informed consent
Key exclusion criteria (4 listed)
- Allergy to local anesthetics or any drugs involve in the study
- Controindication to regional anesthesia
- chronic use of opioids
- BMI > 35 kg m2
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 |
|---|---|---|
| continuous peripheral nerve blockcontinuous regional anesthesia in total knee replacement | Procedure or surgery | fast track, traditional |
Primary outcome
Persistent post surgical pain
Time frame: 0-6-month
Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement
2 secondary outcomes
acute postoperative pain
Time frame: 0-72 hours
Morphine requirement
Time frame: 0-72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous peripheral nerve block in people with Knee Arthropathy, run by Policlinico di Monza SpA at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Cappelleri, MD (+390392810941, gianluca.cappelleri@policlinicodimonza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent post surgical pain (time frame: 0-6-month). 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 21 Sep 2026.