NCT03954379

IPACK Study in Total Knee Arthroplasty Patients

Opioid Sparing Analgesic Strategies for Enhanced Recovery After Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Knee Replacement Arthroplasty

Interventions

Type	Name	Description
DRUG	Standard of Care (ACB, SA, peri-op pain management)	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
DRUG	IPACK and multi-modal analgesic regimen	INTERVENTION BEFORE SURGERY 1. Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication 2. iPACK block ( infiltration between Popliteal Artery and posterior Capsule of the Knee) - injection of freezing medication in the back of the knee INTERVENTION DURING SURGERY 1. IV dexmedetomidine 2. IV ketamine Both for sedation INTERVENTION AFTER SURGERY 1. injection of freezing medication through the tube in the thigh x 2 2. IV dexamethasone 8 mg 1 day after surgery
PROCEDURE	Periarticular Local Anesthetic Infiltration	INTERVENTION DURING SURGERY
DRUG	IV Dexamethasone 8mg at the end of surgery as standard of care	INTERVENTION DURING SURGERY

Timeline

• Start date: 2019-10-24
• Primary completion: 2020-12-02
• Completion: 2021-03-31
• First posted: 2019-05-17
• Last updated: 2022-04-29

Locations

1 site across 1 country: Canada