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RecruitingNCT06182059Updated Sep 21, 2026

Persistent Post Surgical Pain After Total Knee Arthroplasty

An interventional study of continuous peripheral nerve block in Knee Arthropathy, sponsored by Policlinico di Monza SpA. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Policlinico di Monza SpA · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
436
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Knee Arthropathy

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Keywords

  • knee arthroplasty
  • acute postoperative pain
  • persistent post surgical pain
  • regional anesthesia
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's planned enrollment of 436 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

This is the only study on the registry with Policlinico di Monza SpA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • primary total knee replacement with a written informed consent

Exclusion criteria

Exclusion Criteria:

  • Allergy to local anesthetics or any drugs involve in the study
  • Controindication to regional anesthesia
  • chronic use of opioids
  • BMI > 35 kg m2
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
436 participants (estimated)

Study arms

  • Active comparator
    fast track

    continuous adductor canal block and ipack block

    Procedure: continuous peripheral nerve block

  • Experimental
    traditional

    continuous femoral nerve block and continuous sciatic block

    Procedure: continuous peripheral nerve block

Interventions

  • Procedurecontinuous peripheral nerve block

    continuous regional anesthesia in total knee replacement

06

What researchers measure

Primary outcomes

  1. Persistent post surgical pain

    Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement

    Time frame: 0-6-month

Secondary outcomes

  1. acute postoperative pain

    Numeric rating score (0-10) over 4 in POD0, POD1, POD2, POD3

    Time frame: 0-72 hours

  2. Morphine requirement

    total morphine administration via PCA in POD0, POD1, POD2, POD3

    Time frame: 0-72 hours

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06182059
Lead sponsor
Policlinico di Monza SpA
Responsible party
Gianluca Cappelleri (MD, Policlinico di Monza SpA) — Principal investigator
First posted
Dec 26, 2023
Start date
Jan 12, 2024
Primary completion
Jan 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Gianluca Cappelleri, MD
Contact
gianluca.cappelleri@policlinicodimonza.it
+390392810941
Gianluca Perseghin, MD
Contact
gianluca.perseghin@policlinicodimonza.it
+3903928109

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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