IPACK Study in Total Knee Arthroplasty Patients

NCT03954379 | Completed Phase 4 DMC

• 1 other identifier: 18-5920
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Replacement Arthroplasty

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption in MG

  Cumulative 24 hour oral hydromorphone and oxycodone equivalent consumption

  24 hours

Secondary Outcomes (7)

• Pain scores at rest using numerical rating scale (NRS, 0 to 10)

  0-48 hours after surgery

• Opioid consumption in MG

  12 hours to 6 weeks after surgery

• 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

• Time to reach physical therapy milestones in hours

  0-72 hours after surgery

• Time to reach hospital discharge criteria in hours

  24 to 72 hours after surgery until discharge

Study Arms (2)

Group C ( Comparator Group )

ACTIVE COMPARATOR

Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management

Drug: Standard of Care (ACB, SA, peri-op pain management); Procedure: Periarticular Local Anesthetic Infiltration; Drug: IV Dexamethasone 8mg at the end of surgery as standard of care

Group S ( Study Group )

EXPERIMENTAL

iPACK and multi-modal analgesic regimen

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

Interventions

Standard of Care (ACB, SA, peri-op pain management) DRUG

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

Also known as: ACB

Group C ( Comparator Group )

IPACK and multi-modal analgesic regimen DRUG

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

Also known as: Infilteration between popliteal artery and posterior capsule of the knee

Group S ( Study Group )

Periarticular Local Anesthetic Infiltration PROCEDURE

INTERVENTION DURING SURGERY

Also known as: LAI

Group C ( Comparator Group ); Group S ( Study Group )

IV Dexamethasone 8mg at the end of surgery as standard of care DRUG

INTERVENTION DURING SURGERY

Also known as: IV Dexamethasone Infusion

Group C ( Comparator Group ); Group S ( Study Group )

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking;
• Age 18 - 85;
• BMI ≤ 38;
• Undergoing unilateral primary total knee arthroplasty surgery.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Interventions

Standard of Care; Dexamethasone

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Vincent Chan, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Block room and anesthesia staff performing nerve blocks and administering sedation will be informed to which study group patient is allocated. The patient and independent investigator carrying out follow up assessments will remain blinded to the end of the study. If the patient wishes to know the study group assignment, the patient will be informed at the end of their final 6 week follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 17, 2019
• Study Start: October 24, 2019
• Primary Completion: December 2, 2020
• Study Completion: March 31, 2021
• Last Updated: April 29, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)