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Clinical Trials/NCT06182059
NCT06182059
Recruiting
Not Applicable

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

Policlinico di Monza SpA1 site in 1 country436 target enrollmentJanuary 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthropathy
Sponsor
Policlinico di Monza SpA
Enrollment
436
Locations
1
Primary Endpoint
Persistent post surgical pain
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2024
End Date
July 31, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Policlinico di Monza SpA
Responsible Party
Principal Investigator
Principal Investigator

Gianluca Cappelleri

MD

Policlinico di Monza SpA

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • acute postoperative pain(0-72 hours)
  • Morphine requirement(0-72 hours)

Study Sites (1)

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