Knee Replacement, TotalPhase 4NCT02474654
Implementation of a Pain Management Protocol for Total Knee Arthroplasty
A Phase 4 study testing Bupivicaine, Fentanyl and Epimorphine in people with Knee Replacement, Total, run by Health Sciences North Research Institute at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Replacement, Total
- What is being tested?
- Bupivicaine, Fentanyl and Epimorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 14 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- primary total knee replacement for osteoarthritis
- agrees to a spinal anesthetic for TKR
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1
About this study
Official title: 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)?
Read the 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:
- 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
- Knee Replacement, Total
- Being tested
- Bupivicaine, Fentanyl, Epimorphine, Normal Saline, Ropivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivicaineDrug
15mg
FentanylDrug
15mcg
EpimorphineDrug
150mcg
Normal SalineDrug
0.3 ml
Normal SalineDrug
30ml
Normal SalineDrug
100 ml
RopivicaineDrug
100 ml
EpinephrineDrug
600 mcg
KetorolacDrug
30 mg
Ropivicaine with EpinephrineDrug
0.5% 1:400,000 30ml
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PI+FNB+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg Receives: Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Ropivicaine with Epinephrine |
| Arm 2:NS+FNB+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml Receives: Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline; Drug: Ropivicaine with Epinephrine |
| Arm 3: PI+NS+IO | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg Receives: Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac |
| Arm 4: PI+FNB+NS | Experimental | Bupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg Receives: Drug: Bupivicaine; Drug: Fentanyl; Drug: Normal Saline; Drug: Ropivicaine; Drug: Epinephrine; Drug: Ketorolac; Drug: Ropivicaine with Epinephrine |
| Arm 5:NS+NS+IO | Active comparator | Bupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml Receives: Drug: Bupivicaine; Drug: Fentanyl; Drug: Epimorphine; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Discharge
Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days
Measured: Post-op day 1 to discharge date or day 5
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Post-op day 0 to discharge date or day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim E Wong, MD, FRCPC, BSc, PT, Principal investigator, Health Sciences North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474654
- Sponsor's protocol ID
- 15-009
- Status last verified
- Jan 2019
- First submitted
- 6 May 2015
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02474654
- Acronym / sponsor ID
- 15-009
- Conditions
- Knee Replacement, Total
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PI+FNB+IO | Experimental | Drug: Bupivicaine, Drug: Fentanyl, Drug: Epimorphine, Drug: Ropivicaine, Drug: Epinephrine, Drug: Ketorolac, Drug: Ropivicaine with EpinephrineBupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
| Arm 2:NS+FNB+IO | Experimental | Drug: Bupivicaine, Drug: Fentanyl, Drug: Epimorphine, Drug: Normal Saline, Drug: Ropivicaine with EpinephrineBupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, 0.5% Ropivicaine with1:400,000 Epinephrine 30ml, Normal Saline 100ml |
| Arm 3: PI+NS+IO | Experimental | Drug: Bupivicaine, Drug: Fentanyl, Drug: Epimorphine, Drug: Normal Saline, Drug: Ropivicaine, Drug: Epinephrine, Drug: KetorolacBupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
| Arm 4: PI+FNB+NS | Experimental | Drug: Bupivicaine, Drug: Fentanyl, Drug: Normal Saline, Drug: Ropivicaine, Drug: Epinephrine, Drug: Ketorolac, Drug: Ropivicaine with EpinephrineBupivicaine 15mg, Fentanyl 15mcg, Normal Saline 0.3ml, 0.5% Ropivicaine with 1:400,000 Epinephrine 30ml, Ropivicaine 100ml, Epinephrine 600mcg, Ketorolac 30mg |
| Arm 5:NS+NS+IO | Active comparator | Drug: Bupivicaine, Drug: Fentanyl, Drug: Epimorphine, Drug: Normal SalineBupivicaine 15mg, Fentanyl 15mcg, Epimorphine 150mcg, Normal Saline 30ml, Normal Saline 100ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- primary total knee replacement for osteoarthritis
- agrees to a spinal anesthetic for TKR
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivicaine15mg | Drug | Arm 1: PI+FNB+IO, Arm 2:NS+FNB+IO, Arm 3: PI+NS+IO, Arm 4: PI+FNB+NS, Arm 5:NS+NS+IO |
| Fentanyl15mcg | Drug | Arm 1: PI+FNB+IO, Arm 2:NS+FNB+IO, Arm 3: PI+NS+IO, Arm 4: PI+FNB+NS, Arm 5:NS+NS+IO |
| Epimorphine150mcg | Drug | Arm 1: PI+FNB+IO, Arm 2:NS+FNB+IO, Arm 3: PI+NS+IO, Arm 5:NS+NS+IO |
| Normal Saline0.3 ml | Drug | Arm 4: PI+FNB+NS |
| Normal Saline30ml | Drug | Arm 3: PI+NS+IO, Arm 5:NS+NS+IO |
| Normal Saline100 ml | Drug | Arm 2:NS+FNB+IO, Arm 5:NS+NS+IO |
| Ropivicaine100 ml | Drug | Arm 1: PI+FNB+IO, Arm 3: PI+NS+IO, Arm 4: PI+FNB+NS |
| Epinephrine600 mcg | Drug | Arm 1: PI+FNB+IO, Arm 3: PI+NS+IO, Arm 4: PI+FNB+NS |
| Ketorolac30 mg | Drug | Arm 1: PI+FNB+IO, Arm 3: PI+NS+IO, Arm 4: PI+FNB+NS |
| Ropivicaine with Epinephrine0.5% 1:400,000 30ml | Drug | Arm 1: PI+FNB+IO, Arm 2:NS+FNB+IO, Arm 4: PI+FNB+NS |
Primary outcome
Time to Discharge
Time frame: Post-op day 1 to discharge date or day 5
Meeting discharge criteria - Participants will be followed for the duration of hospital stay, approximately 3-5 days
3 secondary outcomes
Time up and go performance measures
Time frame: Post-op day1 to discharge date or day 5
Total Opioid Consumption Measures
Time frame: Post-op day 0 to discharge date or day 5
Complications
Time frame: Post-op day 0 to discharge date or day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim E Wong, MD, FRCPC, BSc, PT principal investigator
Health Sciences North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivicaine, Fentanyl and Epimorphine in people with Knee Replacement, Total, run by Health Sciences North Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Discharge (time frame: Post-op day 1 to discharge date or day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.