Knee Replacement Arthroplasty Clinical Trial
Official title:
Opioid Sparing Analgesic Strategies for Enhanced Recovery After Total Knee Arthroplasty
Verified date | March 2021 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | March 31, 2021 |
Est. primary completion date | December 2, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hopspital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative opioid consumption in MG | Cumulative 24 hour oral hydromorphone and oxycodone equivalent consumption | 24 hours | |
Secondary | Pain scores at rest using numerical rating scale (NRS, 0 to 10) | 0, 12, 18, 24, 36 and 48 hours after surgery and also pain scores during physical therapy daily | 0-48 hours after surgery | |
Secondary | Opioid consumption in MG | Analgesic consumption at 12, 18, 36 and 48 hours and 1, 2 and 6 weeks after surgery | 12 hours to 6 weeks after surgery | |
Secondary | Quality of Recovery (QoR) assessed using a validated QoR-15 tool ( Total score range- 0 to 150, higher values represent a better outcome) | Treatment effect will be estimated using a linear regression model, with baseline QoR score as a covariate. | Baseline, 24-hour, 48-hour and 2-weeks after surgery | |
Secondary | Time to reach physical therapy milestones in hours | The post TKA milestones are: knee flexion = 90 degrees, get in and out of bed by self, safe transfer to bathroom with or without assistance, walk with an assistive device on a level surface for a short distance and being able to climb up and down 2 or 3 stairs. steps or flights of stairs? | 0-72 hours after surgery | |
Secondary | Time to reach hospital discharge criteria in hours | The 4 criteria are: 1) adequate analgesia (numerical rating scale <4/10); 2) independence from IV opioids = 12 hours; 3) ability to independently stand and sit down (evaluated with the Timed Up and Go test and 4) unassisted ambulation = 30 mins (evaluated with the 6-min walk test) | 24 to 72 hours after surgery until discharge | |
Secondary | Incidence of adverse events related to nerve block procedures | muscle weakness, systemic toxicity | Post-op 24 to 72 hours | |
Secondary | Incidence of adverse events related to opioid consumption | nausea, vomiting, dizziness, sedation | Post-op 24 to 72 hours |
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