Implementation of a Pain Management Protocol for Total Knee Arthroplasty

An Analysis of the Functional Benefit, Narcotic Use and Time to Discharge Readiness Following the Implementation of a Comprehensive Pain Management Protocol for Primary Total Knee Arthroplasty

Study question: Is there an ideal combination of intraoperative long acting analgesics (periarticular infiltration (PI), femoral nerve block (FB) and intrathecal opioids (IO)) to optimize post-operative functional recovery, decrease overall narcotic consumption and enable faster 'readiness to discharge' for patients undergoing primary total knee replacement (TKR)?

Study Overview

• Status: Completed
• Conditions: Knee Replacement, Total
• Intervention / Treatment: Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Ropivicaine with Epinephrine; Drug: Normal Saline; Drug: Normal Saline; Drug: Normal Saline

Detailed Description

Our study design is a five-arm double blinded randomized control trial. In order to create a blinded study, each participant will have all three interventions (Femoral Nerve Block (FB), Periarticular Injection (PI) and Intrathecal Opioid (IO)) performed during their visit. Normal saline (NS) will be substituted for opioid or local anesthetic in cases where a control is required.

Specific 5 arms include:

• Using all three anesthetics:

  o PI + FB + IO (arm 1)

• Using a combination of two anesthetics + normal saline substitute for control:

  • NS + FB + IO (arm 2)
  • PI + NS + IO (arm 3)
  • PI + FB + NS (arm 4)

• Control:

  • NS + NS + IO (arm 5)

The control arm would include IO as the sole intervention as this is simply added to the spinal anesthetic used for the surgery itself. It is felt that having a study arm without any long-acting analgesic medication (opioid or local anesthetic) as the "control" arm following a spinal anesthetic would not meet current standard of care and cause harm to the participant

The investigators hypothesize that the combination of three forms of long acting analgesia (PI, FB, IO) will result in the greatest outcomes compared to a combination of any two or control. Our aim is to demonstrate that this optimal analgesic combination will have an additive pain control effect and will minimize side effects thus translating to less acute pain, improve patient mobility, and attaining "readiness to discharge" quicker.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older
• primary total knee replacement for osteoarthritis
• agrees to a spinal anesthetic for TKR

Exclusion Criteria:

• History of chronic pain or opioid tolerance (individuals requiring equivalent of 1 mg or more intravenous or 3 mg or more oral morphine per hour for greater than 1 month)
• general anesthetic for TKR
• major neurological deficit
• allergy to local anesthetic
• allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
• renal insufficiency
• liver failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: PI+FNB+IO; Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg	Drug: Bupivicaine; 15mg; Drug: Fentanyl; 15mcg; Drug: Epimorphine; 150mcg; Drug: Ropivicaine; 100 ml; Drug: Epinephrine; 600 mcg; Drug: Ketorolac; 30 mg; Drug: Ropivicaine with Epinephrine; 0.5% 1:400,000 30ml
Experimental: Arm 2:NS+FNB+IO; Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml	Drug: Bupivicaine; 15mg; Drug: Fentanyl; 15mcg; Drug: Epimorphine; 150mcg; Drug: Ropivicaine with Epinephrine; 0.5% 1:400,000 30ml; Drug: Normal Saline; 0.3 ml; Drug: Normal Saline; 30ml; Drug: Normal Saline; 100 ml
Experimental: Arm 3: PI+NS+IO; Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg	Drug: Bupivicaine; 15mg; Drug: Fentanyl; 15mcg; Drug: Epimorphine; 150mcg; Drug: Ropivicaine; 100 ml; Drug: Epinephrine; 600 mcg; Drug: Ketorolac; 30 mg; Drug: Normal Saline; 0.3 ml; Drug: Normal Saline; 30ml; Drug: Normal Saline; 100 ml
Experimental: Arm 4: PI+FNB+NS; Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg	Drug: Bupivicaine; 15mg; Drug: Fentanyl; 15mcg; Drug: Ropivicaine; 100 ml; Drug: Epinephrine; 600 mcg; Drug: Ketorolac; 30 mg; Drug: Ropivicaine with Epinephrine; 0.5% 1:400,000 30ml; Drug: Normal Saline; 0.3 ml; Drug: Normal Saline; 30ml; Drug: Normal Saline; 100 ml
Active Comparator: Arm 5:NS+NS+IO; Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml	Drug: Bupivicaine; 15mg; Drug: Fentanyl; 15mcg; Drug: Epimorphine; 150mcg; Drug: Normal Saline; 0.3 ml; Drug: Normal Saline; 30ml; Drug: Normal Saline; 100 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discharge	Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day 1 to discharge date or day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time up and go performance measures	Measured by physiotherapists - Functional Outcome - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day1 to discharge date or day 5
Total Opioid Consumption Measures	Narcotic Use and Assessment - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day 0 to discharge date or day 5
Complications	To include nausea, vomiting, pruritis as assessed by Common Terminology Criteria for Adverse Events (CTCAE) - Participants will be followed for the duration of hospital stay, approximately 3-5 days	Post-op day 0 to discharge date or day 5

Collaborators and Investigators

• Sponsor: Health Sciences North Research Institute
• Investigators: Principal Investigator: Kim Wong, MD, FRCPC, BSc, PT, Health Sciences North

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 14, 2019
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Fentanyl; Ketorolac; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 15-009