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NCT06182059 Clinical Trial

Persistent Post Surgical Pain After Total Knee Arthroplasty

Knee Arthropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06182059
Other study ID # PPSP PTG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 12, 2024
Est. completion date July 31, 2025

Study information
Verified date January 2024
Source Policlinico di Monza SpA
Contact Gianluca Cappelleri, MD
Phone +390392810941
Email gianluca.cappelleri@policlinicodimonza.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 436
Est. completion date July 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• continuous peripheral nerve block
continuous regional anesthesia in total knee replacement

Locations
Country Name City State
Italy Policlinico di Monza SPA Monza Monza Brianza

Sponsors (1)
Lead Sponsor Collaborator
Policlinico di Monza SpA

Country where clinical trial is conducted

Italy, 

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