Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to compare different medication combinations used in a
      periarticular injection after total knee replacement surgery(TKR). A periarticular injection
      is an injection that is given into the tissues surrounding the knee joint. The injection is
      given while the patient is still in surgery.

      The study will compare the level of pain management, length of hospital stay, range of motion
      and side effects from subjects receiving one of four different combinations of medication in
      a periarticular injection. The medications used in the injections are approved medications
      routinely used for pain management.

      Approximately 160 subjects will participate in this study. The surgeon, study personnel, and
      patients will be blinded to the combination of medications each patient receives. The
      pharmacist will prepare the 4 different combinations of medications, randomize each patient
      to the particular combination of medications, and maintain the study drug documentation.
    

Detailed description: 
      Data Collection:

      Data will be collected from the patient's pre-operative office visit, up to six weeks
      post-operatively.

      Variables

      Pre-operative Collection:

        -  Vital signs

        -  Hb/Hct

        -  Age

        -  Sex

        -  BMI

        -  WOMAC Score - Screen Failure at 36 or 12

        -  Visual Analog Scale (VAS)

      Intra-operative Collection:

        -  Duration of surgery

        -  Tourniquet time

        -  Time of periarticular injection

      Post-operative Collection:

        -  Pain Scores in the inpatient post-anesthesia care unit (PACU) using the 1- to 10- point
           Visual Analog Scale (VAS) an admission to unit, 1 hour, 2 hour, and on discharge.

        -  VAS pain scores every 8 hours on the Orthopaedic floor

        -  Use of supplementary narcotics

        -  Use of anti-emetics

        -  Serious Adverse Events (SAE) including deep vein thrombosis (DVT) formation, pulmonary
           embolism (PE), myocardial infarct or other serious cardiac event, excessive bleeding

        -  Length of hospital stay

        -  Requirement for inpatient rehabilitation versus discharge home

        -  Hours/Days to straight leg raise -POD 1, 2, 3 by MD on rounds.

        -  Days to independent ambulation

        -  Hemoglobin and Hematocrit levels on post-operative days one and two

        -  Presence/Absence of Bowel/Bladder Function

      Data to be Collected by Physical Therapist: POD 1, 2, 3, Numerical Rating Scale (NRS) Pain
      with Ambulation

        -  Use of Assisted Devices

        -  Distance walked

        -  Range of Motion(ROM) (using Goniometer)- active and passive.

      Treatment Periods Screening Visit Day 0 - Day of surgery Visit Day 1, 2, 3 (Post-operative
      days 1, 2, and 3) 6 Week visit in Office
    

Intervention name(s): Ropivacaine; Toradol; Clonidine; Epinephrine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ropivacaine 5mg/ml (49.25 ml); Toradol 30mg/ml (1 ml); Clonidine 0.1 mg/ml (0.08mg - 0.8 ml); Epinephrine 1 mg/ml (0.5 ml)
Other intervention name(s): periarticular injection; periarticular injection; periarticular injection; periarticular injection
Intervention MeSH terms: Ketorolac Tromethamine; Clonidine; Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; postoperative pain; periarticular; arthroplasty; pain management