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NCT Number: NCT06182059

Persistent Post Surgical Pain After Total Knee Arthroplasty

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

Recruiting

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Key information

Conditions

Knee Arthropathy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous peripheral nerve block

Procedure

continuous regional anesthesia in total knee replacement

Primary outcomes

  1. 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

Secondary outcomes

  1. acute postoperative pain

    Time frame: 0-72 hours

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

  2. Morphine requirement

    Time frame: 0-72 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Cappelleri, MD

CONTACT

[email protected]

+390392810941

Gianluca Perseghin, MD

CONTACT

[email protected]

+3903928109

Sponsors and collaborators

Lead sponsor

Policlinico di Monza SpA

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 26, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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