Osteoarthritis, KneePhase 4NCT02570503
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine, Ketorolac and Clonidine in people with Osteoarthritis, Knee, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ropivacaine, Ketorolac and Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 11 Feb 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Written informed consent
Who cannot join
- Pregnant women
- Creatinine clearance less than 60 ml/min
- BMI greater than 40
- Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
- Receive a unicondylar knee replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
Read more
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Read the detailed description
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
- Age
- Sex
- BMI
- UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
- Patient's assessment of acceptability of pain
- UPAT score as assessed by physical therapy pre and post therapy sessions
- Duramorph dose
- Time patient arrived on the Orthopedic Unit
- Length of ambulation during physical therapy sessions
- Amount of supplementary opioids (measured in morphine equivalents)
- Use of anti-emetics
- Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
- Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ropivacaine, Ketorolac, Clonidine, Epinephrine, 0.9% sodium chloride
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called periarticular injection
Ropivacaine (5mg/ml)-50ml
KetorolacDrug
Also called periarticular injection
ketorolac (30mg/ml)- 1 ml
ClonidineDrug
Also called periarticular injection
clonidine (0.1mg/ml)- 0.8ml
EpinephrineDrug
Also called periarticular injection
epinephrine (1mg/ml)-1ml
0.9% sodium chlorideDrug
Also called periarticular injection
Sodium chloride 0.9%- 47.7 ml
| Study group | Role | What they receive |
|---|---|---|
| ROP/KET/CLON/EPI/SAL | Experimental | Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml Receives: Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine; Drug: Epinephrine; Drug: 0.9% sodium chloride |
| Placebo | Placebo comparator | 0.9% Sodium Chloride- 100ml Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Universal Pain Assessment Tool (UPAT)
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Measured: 3 days after surgery
Narcotic Use During Hospitalization
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
Measured: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
Secondary outcomes (3)
Patient's Subjective Rating of Pain
Patients are asked if their pain is acceptable (yes/no)
Measured: 3 days after surgery
UPAT Score Before and After Physical Therapy
Pain in score change after physical therapy
Measured: 3 days after surgery
Ambulation During Physical Therapy
The length (in feet) patient is able to ambulate during physical therapy
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Why it stopped: Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Golladay, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570503
- Sponsor's protocol ID
- HM20004125
- Status last verified
- Mar 2022
- First submitted
- 5 Oct 2015
- Last updated
- 4 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Intraoperative Periarticular Injections Improve Postoperative Pain Control in Patients Receiving Duramorph (Preservative Free) During Total Knee Arthroplasty? A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02570503
- Acronym / sponsor ID
- HM20004125
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study's primary aims are no longer clinically impactful, as intrathecal morphine has fallen out of favor and replaced with different agents so that outpatient/23 hr surgery is more predictably achievable.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 4 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.
Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.
All patients will also receive a long-acting (24 hours) morphine injection during surgery.
The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.
Detailed description
Data Collection:
Data will be collected from the patient's medical record after discharge
Variables include:
- Age
- Sex
- BMI
- UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
- Patient's assessment of acceptability of pain
- UPAT score as assessed by physical therapy pre and post therapy sessions
- Duramorph dose
- Time patient arrived on the Orthopedic Unit
- Length of ambulation during physical therapy sessions
- Amount of supplementary opioids (measured in morphine equivalents)
- Use of anti-emetics
- Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
- Length of hospital stay
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROP/KET/CLON/EPI/SAL | Experimental | Drug: Ropivacaine, Drug: Ketorolac, Drug: Clonidine, Drug: Epinephrine, Drug: 0.9% sodium chlorideRopivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml |
| Placebo | Placebo comparator | Drug: 0.9% sodium chloride0.9% Sodium Chloride- 100ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Written informed consent
Key exclusion criteria (5 listed)
- Pregnant women
- Creatinine clearance less than 60 ml/min
- BMI greater than 40
- Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
- Receive a unicondylar knee replacement
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 |
|---|---|---|
| RopivacaineAlso: periarticular injectionRopivacaine (5mg/ml)-50ml | Drug | ROP/KET/CLON/EPI/SAL |
| KetorolacAlso: periarticular injectionketorolac (30mg/ml)- 1 ml | Drug | ROP/KET/CLON/EPI/SAL |
| ClonidineAlso: periarticular injectionclonidine (0.1mg/ml)- 0.8ml | Drug | ROP/KET/CLON/EPI/SAL |
| EpinephrineAlso: periarticular injectionepinephrine (1mg/ml)-1ml | Drug | ROP/KET/CLON/EPI/SAL |
| 0.9% sodium chlorideAlso: periarticular injectionSodium chloride 0.9%- 47.7 ml | Drug | Placebo, ROP/KET/CLON/EPI/SAL |
Primary outcome
Universal Pain Assessment Tool (UPAT)
Time frame: 3 days after surgery
Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.
Narcotic Use During Hospitalization
Time frame: 0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period
The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.
3 secondary outcomes
Patient's Subjective Rating of Pain
Time frame: 3 days after surgery
UPAT Score Before and After Physical Therapy
Time frame: 3 days after surgery
Ambulation During Physical Therapy
Time frame: 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gregory Golladay, MD principal investigator
Virginia Commonwealth University
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 Ropivacaine, Ketorolac and Clonidine in people with Osteoarthritis, Knee, run by Virginia Commonwealth University at 1 site in United States.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Mar 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Universal Pain Assessment Tool (UPAT) (time frame: 3 days after surgery). The study lists 2 primary outcomes in all. 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 4 Mar 2022.