NCT06182059

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jan 2024Jul 2027

First Submitted

Initial submission to the registry

December 5, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 12, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

December 5, 2023

Last Update Submit

May 28, 2025

Conditions

Knee Arthropathy

Keywords

knee arthroplastyacute postoperative painpersistent post surgical painregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Persistent post surgical pain

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

    0-6-month

Secondary Outcomes (2)

  • acute postoperative pain

    0-72 hours

  • Morphine requirement

    0-72 hours

Study Arms (2)

fast track

ACTIVE COMPARATOR

continuous adductor canal block and ipack block

Procedure: continuous peripheral nerve block

traditional

EXPERIMENTAL

continuous femoral nerve block and continuous sciatic block

Procedure: continuous peripheral nerve block

Interventions

continuous peripheral nerve blockPROCEDURE

continuous regional anesthesia in total knee replacement

fast tracktraditional

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary total knee replacement with a written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico di Monza SPA

Monza, Monza Brianza, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Gianluca Cappelleri, MD

CONTACT

+390392810941gianluca.cappelleri@policlinicodimonza.it

Gianluca Perseghin, MD

CONTACT

+3903928109gianluca.perseghin@policlinicodimonza.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 26, 2023

Study Start

January 12, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations

IT(1)