Overview

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)