Persistent Post Surgical Pain After Total Knee Arthroplasty

May 28, 2025 updated by: Gianluca Cappelleri, Policlinico di Monza SpA

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fast track
continuous adductor canal block and ipack block
Procedure: continuous peripheral nerve block
continuous regional anesthesia in total knee replacement
Experimental: traditional
continuous femoral nerve block and continuous sciatic block
Procedure: continuous peripheral nerve block
continuous regional anesthesia in total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute postoperative pain
Time Frame: 0-72 hours
Numeric rating score (0-10) over 4 in POD0, POD1, POD2, POD3
0-72 hours
Morphine requirement
Time Frame: 0-72 hours
total morphine administration via PCA in POD0, POD1, POD2, POD3
0-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico di Monza SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPSP PTG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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