Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      BACKGROUND

      Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly
      recommended as part of the perioperative pain treatment. Whether catheter-based techniques
      are better than single injection techniques are debatable. Furthermore, in catheter-based
      techniques, whether a low-dose automated, periodic infusion can produce similar analgesic
      effectiveness compared to a conventional, high dose, continuous infusion has never been
      explored.

      AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a
      conventional continuous infusion and patient-controlled boluses only in catheter-based
      adductor canal blocks for patients undergoing total knee arthrplasty.
    

Detailed description: 
      BACKGROUND

      Total knee arthroplasty (TKA) is a very common procedure, with more than 600.000 being
      performed annually in the US alone. This number is expected to increase to more than 3
      million by 2030. The procedure is associated with intense, early postoperative pain, and half
      of the patients report moderate to severe pain the first 2-3 postoperative days (POD).
      Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly
      recommended as part of a multimodal, perioperative, analgesic treatment.

      Patients who are expected to have postoperative, severe pain exceeding the duration of a
      single injection nerve block may benefit from a catheter-based nerve block (CBNB) using
      either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA).
      Intermittent boluses can be either patient-controlled or prescribed in combination with a
      continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is
      superior to a single injection nerve block after orthopedic surgery remains unanswered. There
      are several challenges when using a CBNB treatment: The dosing or delivery method may be
      either insufficient and thus not pain relieving or too powerful resulting in dense motor
      block and limb anesthesia which may compromise safety and rehabilitation. The peripheral
      nerve block catheter may also displace and therefore deposit LA too far from the targeted
      nerve(s) to produce an effective nerve block.

      Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI.
      It seems that an API produces better pain control, a lower analgesic consumption over time
      and less motor inhibition. This is welldescribed for epidural catheters for laboring women,
      but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve
      block treatment may even out the difference in pain scores between API and CI.

      However, it seems that API groups require less LA via PCA function. Reducing LA consumption
      is of great importance for ambulatory patients whose LA reservoir is limited, but also for
      all other orthopedic patients whose motor block should be minimized in order to optimize
      rehabilitation.

      OBJECTIVES

      To investigate whether a low-dose API with patient-controlled bolus option can produce a
      similar analgesic effect compared to a conventional, high dose, CI with patient-controlled
      bolus option in catheter-based peripheral nerve blocks for patients undergoing total knee
      arthrplasty.

      Analgesic effectiveness will be compared with a group only given the patient controlled bolus
      option.

      HYPOTHESIS

      Low dose API with supplemental patient-controlled bolus option will provide pain-relieving
      therapy not inferior to a conventional CI with supplemental patient-controlled bolus option.
      The intervention group receiving patient-controlled boluses only will experience more pain
      breakthrough.
    

Intervention name(s): Ropivacaine 0.2%
Intervention type(s): Drug
Intervention description(s): Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.
Other intervention name(s): Naropin 0.2%
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 arms (API, CI and PCA only)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral regional anesthesia