A Phase 4 interventional study of Bupivicaine and Fentanyl in Knee Replacement, Total, sponsored by Health Sciences North Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Health Sciences North Research Institute · Phase 4, Interventional, and Treatment
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)?
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:
Control:
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.
Health Sciences North Research Institute is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
Drug: Bupivicaine · Drug: Fentanyl · Drug: Epimorphine · Drug: Ropivicaine · Drug: Epinephrine · Drug: Ketorolac · Drug: Ropivicaine with Epinephrine
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml
Drug: Bupivicaine · Drug: Fentanyl · Drug: Epimorphine · Drug: Normal Saline · Drug: Ropivicaine with Epinephrine
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg
Drug: Bupivicaine · Drug: Fentanyl · Drug: Epimorphine · Drug: Normal Saline · Drug: Ropivicaine · Drug: Epinephrine · Drug: Ketorolac
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 · Drug: Fentanyl · Drug: Normal Saline · Drug: Ropivicaine · Drug: Epinephrine · Drug: Ketorolac · Drug: Ropivicaine with Epinephrine
Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml
Drug: Bupivicaine · Drug: Fentanyl · Drug: Epimorphine · Drug: Normal Saline
15mg
15mcg
150mcg
0.3 ml
30ml
100 ml
100 ml
600 mcg
30 mg
0.5% 1:400,000 30ml
Time to Discharge
Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Time frame: Post-op day 1 to discharge date or day 5
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
Time frame: 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
Time frame: 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
Time frame: Post-op day 0 to discharge date or day 5
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Health Sciences North Research Institute