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Persistent Post Surgical Pain After Total Knee Arthroplasty

NCT ID: NCT06182059

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2027-07-31

Brief Summary

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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

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Detailed Description

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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

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Knee Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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fast track

continuous adductor canal block and ipack block

Group Type ACTIVE_COMPARATOR

continuous peripheral nerve block

Intervention Type PROCEDURE

continuous regional anesthesia in total knee replacement

traditional

continuous femoral nerve block and continuous sciatic block

Group Type EXPERIMENTAL

continuous peripheral nerve block

Intervention Type PROCEDURE

continuous regional anesthesia in total knee replacement

Interventions

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continuous peripheral nerve block

continuous regional anesthesia in total knee replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary total knee replacement with a written informed consent

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico di Monza SpA

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Cappelleri

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico di Monza SPA

Monza, Monza Brianza, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gianluca Cappelleri, MD

Role: CONTACT

[email protected]
+390392810941

Gianluca Perseghin, MD

Role: CONTACT

[email protected]
+3903928109

Facility Contacts

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Gianluca Cappelleri, MD

Role: primary

[email protected]
+390392810941

Gianluca Perseghin, MD

Role: backup

[email protected]
+3903928109

Other Identifiers

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PPSP PTG

Identifier Type: -

Identifier Source: org_study_id

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