Toronto Western Hopspital
Toronto, Ontario, M5T2S8, Canada
NCT Number: NCT03954379
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M5T2S8, Canada
Total knee replacement surgery (TKA) causes severe pain and this procedure is the most common reason patients are prescribed strong opioid drugs in hospital. As a result they are slow to begin rehabilitation after surgery, and are late in hospital discharge. Ontario hospitals are constantly challenged to meet growing demands of TKA and in fact increased demand has overcome the health care system resulting in TKA wait time (Ontario actual: 286 days vs. target: 182 days).1 One strategy to accommodate expanding volume and reduce wait time is to reduce hospital length of stay (LOS) through an enhanced recovery program.2 One essential component is further improvement of postoperative pain treatment to expedite rehabilitation and hospital discharge.
Treatment of severe post TKA pain often requires potent opioids but their excessive and prolonged use has negative consequences e.g., increased perioperative adverse events and longer LOS.3 Approximately 8% of opioid naive TKA patients become chronic opioid users at 6 months and the duration of prescription is the strongest predictor of misuse.4 Knowing that the opioid crisis in Canada is steadily growing and prescription opioids play a significant role in dependence and misuse,5 an effective perioperative opioid minimization analgesic program is mandatory for TKA patients.
Current multimodal analgesic treatment for TKA consists of oral non opioid drugs e.g., acetaminophen and non steroidal anti-inflammatory agents (NSAIDs) and surgeon performed peri-articular local anesthesia infiltration, however this is only partially effective.6 The regional analgesic effect is often short lived (< 8 hours). Failure to sustain effective analgesia necessitates continued heavy reliance on opioids.
Several new treatments have been recently described for post TKA pain. They are: IV dexamethasone (steroid),7 dexmedetomidine (alpha 2 agonist)8, ketamine (NMDA antagonist)9 and 2 novel nerve block procedures- adductor canal block10 and iPACK block (infiltration between popliteal artery and posterior capsule of the knee).11 While each individual intervention has demonstrable analgesic benefit, the impact of incorporating all new treatments into the current analgesic regimen remains unknown.
The investigators believe that the new multimodal analgesic regimen proposed in this study will significantly decrease opioid requirement, time to rehabilitation, and time to reach hospital discharge criteria. It may also decrease the duration of opioid prescription for pain relief after hospital discharge. Although investigator's preliminary experience with this new regimen in 10 patients is promising, robust evidence showing its sustained opioid sparing analgesic effect is lacking.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
INTERVENTION BEFORE SURGERY
Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication
INTERVENTION DURING SURGERY
IV propofol for sedation
INTERVENTION AFTER SURGERY
Injection of salty water through the tube in the thigh x 2
Other names: ACB
INTERVENTION BEFORE SURGERY
INTERVENTION DURING SURGERY
INTERVENTION AFTER SURGERY
Other names: Infilteration between popliteal artery and posterior capsule of the knee
INTERVENTION DURING SURGERY
Other names: LAI
INTERVENTION DURING SURGERY
Other names: IV Dexamethasone Infusion
Time frame: 24 hours
Cumulative 24 hour oral hydromorphone and oxycodone equivalent consumption
Time frame: 0-48 hours after surgery
0, 12, 18, 24, 36 and 48 hours after surgery and also pain scores during physical therapy daily
Time frame: 12 hours to 6 weeks after surgery
Analgesic consumption at 12, 18, 36 and 48 hours and 1, 2 and 6 weeks after surgery
Time frame: Baseline, 24-hour, 48-hour and 2-weeks after surgery
Treatment effect will be estimated using a linear regression model, with baseline QoR score as a covariate.
Time frame: 0-72 hours after surgery
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?
Time frame: 24 to 72 hours after surgery until discharge
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)
Time frame: Post-op 24 to 72 hours
muscle weakness, systemic toxicity
Time frame: Post-op 24 to 72 hours
nausea, vomiting, dizziness, sedation
University Health Network, Toronto
Other
Opioid Sparing Analgesic Strategies for Enhanced Recovery After Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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