IPACK Study in Total Knee Arthroplasty Patients
Condition: Knee Replacement Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes to compare current multimodal analgesic treatment for TKA with a new
      multimodal analgesic regimen to demonstrate decreased opioid requirement, time to
      rehabilitation, and time to reach hospital discharge.
    

Detailed description: 
      Total knee replacement surgery (TKA) causes severe pain and this procedure is the most common
      reason patients are prescribed strong opioid drugs in hospital. As a result they are slow to
      begin rehabilitation after surgery, and are late in hospital discharge. Ontario hospitals are
      constantly challenged to meet growing demands of TKA and in fact increased demand has
      overcome the health care system resulting in TKA wait time (Ontario actual: 286 days vs.
      target: 182 days).1 One strategy to accommodate expanding volume and reduce wait time is to
      reduce hospital length of stay (LOS) through an enhanced recovery program.2 One essential
      component is further improvement of postoperative pain treatment to expedite rehabilitation
      and hospital discharge.

      Treatment of severe post TKA pain often requires potent opioids but their excessive and
      prolonged use has negative consequences e.g., increased perioperative adverse events and
      longer LOS.3 Approximately 8% of opioid naive TKA patients become chronic opioid users at 6
      months and the duration of prescription is the strongest predictor of misuse.4 Knowing that
      the opioid crisis in Canada is steadily growing and prescription opioids play a significant
      role in dependence and misuse,5 an effective perioperative opioid minimization analgesic
      program is mandatory for TKA patients.

      Current multimodal analgesic treatment for TKA consists of oral non opioid drugs e.g.,
      acetaminophen and non steroidal anti-inflammatory agents (NSAIDs) and surgeon performed
      peri-articular local anesthesia infiltration, however this is only partially effective.6 The
      regional analgesic effect is often short lived (< 8 hours). Failure to sustain effective
      analgesia necessitates continued heavy reliance on opioids.

      Several new treatments have been recently described for post TKA pain. They are: IV
      dexamethasone (steroid),7 dexmedetomidine (alpha 2 agonist)8, ketamine (NMDA antagonist)9 and
      2 novel nerve block procedures- adductor canal block10 and iPACK block (infiltration between
      popliteal artery and posterior capsule of the knee).11 While each individual intervention has
      demonstrable analgesic benefit, the impact of incorporating all new treatments into the
      current analgesic regimen remains unknown.

      The investigators believe that the new multimodal analgesic regimen proposed in this study
      will significantly decrease opioid requirement, time to rehabilitation, and time to reach
      hospital discharge criteria. It may also decrease the duration of opioid prescription for
      pain relief after hospital discharge. Although investigator's preliminary experience with
      this new regimen in 10 patients is promising, robust evidence showing its sustained opioid
      sparing analgesic effect is lacking.
    

Intervention name(s): Standard of Care (ACB, SA, peri-op pain management); IPACK and multi-modal analgesic regimen; Periarticular Local Anesthetic Infiltration; IV Dexamethasone 8mg at the end of surgery as standard of care
Intervention type(s): Drug; Drug; Procedure; Drug
Intervention description(s): INTERVENTION BEFORE SURGERY
Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication
INTERVENTION DURING SURGERY
IV propofol for sedation
INTERVENTION AFTER SURGERY
Injection of salty water through the tube in the thigh x 2; INTERVENTION BEFORE SURGERY
Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication
iPACK block ( infiltration between Popliteal Artery and posterior Capsule of the Knee) - injection of freezing medication in the back of the knee
INTERVENTION DURING SURGERY
IV dexmedetomidine
IV ketamine Both for sedation
INTERVENTION AFTER SURGERY
injection of freezing medication through the tube in the thigh x 2
IV dexamethasone 8 mg 1 day after surgery; INTERVENTION DURING SURGERY; INTERVENTION DURING SURGERY
Other intervention name(s): ACB; Infilteration between popliteal artery and posterior capsule of the knee; LAI; IV Dexamethasone Infusion
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Analgesics; Anesthetics; Anesthetics, Local; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment