Implementation of a Pain Management Protocol for Total Knee Arthroplasty
NCT ID: NCT02474654
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2015-07-31
2019-01-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Bupivicaine
15mg
Fentanyl
15mcg
Epimorphine
150mcg
Ropivicaine
100 ml
Epinephrine
600 mcg
Ketorolac
30 mg
Ropivicaine with Epinephrine
0.5% 1:400,000 30ml
Arm 2:NS+FNB+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
Bupivicaine
15mg
Fentanyl
15mcg
Epimorphine
150mcg
Normal Saline
100 ml
Ropivicaine with Epinephrine
0.5% 1:400,000 30ml
Arm 3: PI+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
Bupivicaine
15mg
Fentanyl
15mcg
Epimorphine
150mcg
Normal Saline
30ml
Ropivicaine
100 ml
Epinephrine
600 mcg
Ketorolac
30 mg
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
Bupivicaine
15mg
Fentanyl
15mcg
Normal Saline
0.3 ml
Ropivicaine
100 ml
Epinephrine
600 mcg
Ketorolac
30 mg
Ropivicaine with Epinephrine
0.5% 1:400,000 30ml
Arm 5:NS+NS+IO
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
Bupivicaine
15mg
Fentanyl
15mcg
Epimorphine
150mcg
Normal Saline
30ml
Normal Saline
100 ml
Interventions
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Bupivicaine
15mg
Fentanyl
15mcg
Epimorphine
150mcg
Normal Saline
0.3 ml
Normal Saline
30ml
Normal Saline
100 ml
Ropivicaine
100 ml
Epinephrine
600 mcg
Ketorolac
30 mg
Ropivicaine with Epinephrine
0.5% 1:400,000 30ml
Eligibility Criteria
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Inclusion Criteria
* primary total knee replacement for osteoarthritis
* agrees to a spinal anesthetic for TKR
Exclusion Criteria
* general anesthetic for TKR
* major neurological deficit
* allergy to local anesthetic
* allergy to morphine or hydromorphone, anti-inflammatory, acetaminophen
* renal insufficiency
* liver failure
18 Years
ALL
No
Sponsors
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Health Sciences North Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kim Wong, MD, FRCPC, BSc, PT
Role: PRINCIPAL_INVESTIGATOR
Health Sciences North
Locations
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Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
Countries
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Other Identifiers
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15-009
Identifier Type: -
Identifier Source: org_study_id
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