Persistent Post Surgical Pain After Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Knee Arthropathy

• Registration Number: NCT06182059
• Lead Sponsor: Policlinico di Monza SpA

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

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 Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Study Start: 2024-01-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03
• Primary Completion: 2027-01-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 436

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Persistent post surgical pain	0-6-month	Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico di Monza SPA; 🇮🇹 Monza, Monza Brianza, Italy