PainEarly Phase 1NCT02369523
Multimodal Pain Management Following Primary TKA
A Early Phase 1 study testing Exparel, Ropivacaine cocktail (PIC) and Bupivacaine in people with Pain, run by University of Utah at 1 site in United States.
Trial summary
The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- Exparel, Ropivacaine cocktail (PIC) and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2017
- Phase
- Early Phase 1
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 40 Years Old
- Scheduled for Primary Total Knee Arthroplasty
Who cannot join
- Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)
- Neuromuscular deficit affecting the lower limbs
- Peripheral neuropathy
- Radiculopathy/Sciatica
- Known allergy or intolerance to Bupivacaine or Ropivacaine
- Hepatic Disease
Show all 11Show fewer
- Renal Disease/Patients needing Dialysis
- Planned unicompartmental knee replacement
- Less than 90 degree of knee flexion preoperatively.
- Patients who lack the capacity to consent or are unwilling to do so
- At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial
The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.
- Conditions
- Pain
- Being tested
- Exparel, Ropivacaine cocktail (PIC), Bupivacaine
- Keywords
- Primary Total Knee Arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
Ropivacaine cocktail (PIC)Drug
400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
BupivacaineDrug
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| liposomal bupivacaine (LB) (Exparel) | Active comparator | Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®. Receives: Drug: Exparel |
| Ropivacaine cocktail (PIC) | Active comparator | 400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution Receives: Drug: Ropivacaine cocktail (PIC) |
| continuous femoral nerve blocks (cFNB) | Active comparator | Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Discharge Readiness
Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled.
Measured: Participants will be followed for the duration of hospital stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Adequate enrollment was not reached for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pelt, University of Utah
- Investigators
- Christopher Pelt, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369523
- Sponsor's protocol ID
- 74975
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2015
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02369523
- Acronym / sponsor ID
- 74975
- Conditions
- Pain
- Keywords
- Primary Total Knee Arthroplasty
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate enrollment was not reached for this study.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Feb 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.
The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| liposomal bupivacaine (LB) (Exparel) | Active comparator | Drug: ExparelMixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®. |
| Ropivacaine cocktail (PIC) | Active comparator | Drug: Ropivacaine cocktail (PIC)400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution |
| continuous femoral nerve blocks (cFNB) | Active comparator | Drug: BupivacaineContinuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 40 Years Old
- Scheduled for Primary Total Knee Arthroplasty
Key exclusion criteria (11 listed)
- Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)
- Neuromuscular deficit affecting the lower limbs
- Known allergy or intolerance to Bupivacaine or Ropivacaine
- Hepatic Disease
- Renal Disease/Patients needing Dialysis
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 |
|---|---|---|
| ExparelMixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®. | Drug | liposomal bupivacaine (LB) (Exparel) |
| Ropivacaine cocktail (PIC)400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution | Drug | Ropivacaine cocktail (PIC) |
| BupivacaineContinuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours. Sciatic nerve block - 0.125% bupivacaine | Drug | continuous femoral nerve blocks (cFNB) |
Primary outcome
Time to Discharge Readiness
Time frame: Participants will be followed for the duration of hospital stay, an average of 3 days
Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled.
Results and safety
The study was stopped early (reason given: Adequate enrollment was not reached for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
Christopher Pelt, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exparel, Ropivacaine cocktail (PIC) and Bupivacaine in people with Pain, run by University of Utah 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 11 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 15 Aug 2023. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Adequate enrollment was not reached for this study.). Results are not available in the source record.
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 Readiness (time frame: Participants will be followed for the duration of hospital stay, an average of 3 days). 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 15 Aug 2023.