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

Knee Replacement Arthroplasty

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source