IPACK Study in Total Knee Arthroplasty Patients

Phase 4

Completed

• Conditions: Knee Replacement Arthroplasty
• Interventions: Drug: Standard of Care (ACB, SA, peri-op pain management); Drug: IPACK and multi-modal analgesic regimen; Procedure: Periarticular Local Anesthetic Infiltration; Drug: IV Dexamethasone 8mg at the end of surgery as standard of care

• Registration Number: NCT03954379
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-10-24
• Primary Completion: 2020-12-02
• Status Verified: 2021-03
• Study Completion: 2021-03-31
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C ( Comparator Group )	Standard of Care (ACB, SA, peri-op pain management)	Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management
Group C ( Comparator Group )	Periarticular Local Anesthetic Infiltration	Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management
Group C ( Comparator Group )	IV Dexamethasone 8mg at the end of surgery as standard of care	Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management
Group S ( Study Group )	IPACK and multi-modal analgesic regimen	iPACK and multi-modal analgesic regimen
Group S ( Study Group )	Periarticular Local Anesthetic Infiltration	iPACK and multi-modal analgesic regimen
Group S ( Study Group )	IV Dexamethasone 8mg at the end of surgery as standard of care	iPACK and multi-modal analgesic regimen

Primary Outcome Measures

Name	Time	Method
postoperative opioid consumption in MG	24 hours	Cumulative 24 hour oral hydromorphone and oxycodone equivalent consumption

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events related to nerve block procedures	Post-op 24 to 72 hours	muscle weakness, systemic toxicity
Incidence of adverse events related to opioid consumption	Post-op 24 to 72 hours	nausea, vomiting, dizziness, sedation
Quality of Recovery (QoR) assessed using a validated QoR-15 tool ( Total score range- 0 to 150, higher values represent a better outcome)	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 to reach physical therapy milestones in hours	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?
Pain scores at rest using numerical rating scale (NRS, 0 to 10)	0-48 hours after surgery	0, 12, 18, 24, 36 and 48 hours after surgery and also pain scores during physical therapy daily
Opioid consumption in MG	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 to reach hospital discharge criteria in hours	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)

Trial Locations

Locations (1)

Toronto Western Hopspital; 🇨🇦 Toronto, Ontario, Canada