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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 436
- Locations
- 2
- Primary Endpoint
- Persistent post surgical pain
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Gianluca Cappelleri
MD
Policlinico di Monza SpA