CompletedPhase 4Other
IPACK Study in Total Knee Arthroplasty Patients
Sponsored by University Health Network, Toronto
NCT ID
NCT03954379
Target Enrollment
78 participants
Start Date
2019-10-24
Est. Completion
2021-03-31
About This Study
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.
Conditions Studied
Interventions
- •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
Eligibility
Age:18 Years - 85 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion criteria: * English-speaking; * Age 18 - 85; * BMI ≤ 38; * Undergoing unilateral primary total knee arthroplasty surgery. Exclusion criteria: * inability to give informed consent * patient refusal * pregnancy, patients who are breastfeeding * contraindication to nerve blocks or multimodal analgesia * contraindication or hypersensitivity to any of the study drugs (celecoxib, acetaminophen, morphine, ropivacaine, bupivacaine, ketamine, dexmedetomidine, dexamethasone, ketorolac, epinephrine, sulfonamides) * chronic pain disorders (\> 50 mg oral morphine equivalence per day at time of recruitment) * medical or recreational use of marijuana and substance abuse (e.g., alcoholism), * complications after surgery that result in discharge to a location other than home * severe cardiovascular diseases e.g., heart failure, significant dysrhythmias; uncontrolled low blood pressure e.g., systolic blood pressure ≤ 100 mm Hg while on antihypertensive medication(s) * respiratory diseases e.g., severe asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs; severe acute or chronic respiratory disease and obstructive airway * severe or active liver disease * severe inflammatory bowel disease * severe renal impairment (creatinine clearance \<30 mL/min) * uncontrolled diabetes (type 1 or 2) * active bleeding condition (e.g., postoperative or gastro-intestinal bleeding) * severe psychiatric disorders and intake of monoamine oxidase inhibitors * neurologic disorders (e.g., operative extremity neuropathy, delirium tremens, uncontrolled convulsive disorders, increased cerebrospinal or intracranial pressure)
Study Locations (1)
Toronto Western Hopspital
Toronto, Ontario, Canada