IPACK Study in Total Knee Arthroplasty Patients

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Analgesics

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)