Health TrialsbyHealthPanel

Persistent Post Surgical Pain After Total Knee Arthroplasty

ConditionKnee Arthropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPoliclinico di Monza SpA

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary total knee replacement with a written informed consent

Disqualifiers

Allergy to local anesthetics or any drugs involve in the study

Controindication to regional anesthesia

chronic use of opioids

BMI > 35 kg m2

Trial design

Design model

Parallel

Treatments tested in this trial

  • continuous peripheral nerve block

    Procedure/Surgery

    continuous regional anesthesia in total knee replacement

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: fast trackActive comparator 1 intervention
Group B: traditionalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Persistent post surgical pain

Numeric rating score (0-10) over 4 at the follow up 6-month after total knee replacement

Time frame
0-6-month

Secondary outcomes

1

acute postoperative pain

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

Time frame
0-72 hours
2

Morphine requirement

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

Time frame
0-72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Policlinico di Monza SpA

Lead sponsor

Source ClinicalTrials.gov
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