Total Knee ArthroplastyPhase 4NCT02571283
Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
A Phase 4 study testing Cocktail, Exparel and Marcaine in people with Total Knee Arthroplasty and Pain Management, run by University of Louisville.
Trial summary
A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either: 1. a local cocktail. 2. a local cocktail plus Exparel. 3. marcaine plus Exparel prior to wound closure following knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Pain Management
- What is being tested?
- Cocktail, Exparel and Marcaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2016
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained
- The subject underwent a primary total knee replacement under adductor canal block with general anesthesia
Who cannot join
- The subject is a minor
- The subject is on chronic narcotics
- The subject has an indwelling pain pump
- The subject is having a knee revision surgery
- The subject is having a partial knee replacement
- The subject has a history of sepsis in a previously replaced joint
Show all 11Show fewer
- The subject has back pain
- The subject has radicular pain
- The subject suffers from depression
- The subject has fibromyalgia
- The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims
About this study
Official title: A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
Read the detailed description
As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.
Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
METHODOLOGY
Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.
- Conditions
- Total Knee Arthroplasty, Pain Management
- Being tested
- Cocktail, Exparel, Marcaine
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Exparel, Cocktail Injection, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocktailDrug
Also called Naropin, Toradol, Sprix, Acuvail
Administered as a single dose injection.
ExparelDrug
Also called Bupivacaine Liposome
Administered 20 minutes+ before additional medications.
MarcaineDrug
Also called Bupivacaine Hydrochloride, Bupivacaine
Administered 20 minutes or more after Exparel is administered.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Group A [Cocktail Injection] | Experimental | COCKTAIL INJECTION:
Cocktail Injection Consists of:
Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1 mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose Receives: Drug: Cocktail |
| Randomized Group B [Cocktail Injection Plus Exparel] | Experimental | COCKTAIL INJECTION PLUS EXPAREL:
Cocktail Injection Consists of:
Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose Receives: Drug: Cocktail; Drug: Exparel |
| Randomized Group C [Marcaine Plus Exparel] | Experimental | MARCAINE PLUS EXPAREL:
Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose Receives: Drug: Exparel; Drug: Marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively.
Measured: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: PI decided to focus on more current topics of interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Arthroplasty Foundation, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571283
- Sponsor's protocol ID
- 14.1276
- Status last verified
- Apr 2017
- First submitted
- 28 Sep 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
- ClinicalTrials.gov ID
- NCT02571283
- Acronym / sponsor ID
- 14.1276
- Conditions
- Total Knee Arthroplasty, Pain Management
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement, Exparel, Cocktail Injection, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to focus on more current topics of interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Arthroplasty Foundation, Inc.
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Oct 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.
A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
Detailed description
As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.
Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
METHODOLOGY
Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Group A [Cocktail Injection] | Experimental | Drug: CocktailCOCKTAIL INJECTION: Cocktail Injection Consists of: Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1 mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose |
| Randomized Group B [Cocktail Injection Plus Exparel] | Experimental | Drug: Cocktail, Drug: ExparelCOCKTAIL INJECTION PLUS EXPAREL: Cocktail Injection Consists of: Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose |
| Randomized Group C [Marcaine Plus Exparel] | Experimental | Drug: Exparel, Drug: MarcaineMARCAINE PLUS EXPAREL: Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained
- The subject underwent a primary total knee replacement under adductor canal block with general anesthesia
Key exclusion criteria (11 listed)
- The subject is a minor
- The subject is on chronic narcotics
- The subject has an indwelling pain pump
- The subject is having a knee revision surgery
- The subject is having a partial 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 |
|---|---|---|
| CocktailAlso: Naropin, Toradol, Sprix, AcuvailAdministered as a single dose injection. | Drug | Randomized Group A [Cocktail Injection], Randomized Group B [Cocktail Injection Plus Exparel] |
| ExparelAlso: Bupivacaine LiposomeAdministered 20 minutes+ before additional medications. | Drug | Randomized Group B [Cocktail Injection Plus Exparel], Randomized Group C [Marcaine Plus Exparel] |
| MarcaineAlso: Bupivacaine Hydrochloride, BupivacaineAdministered 20 minutes or more after Exparel is administered. | Drug | Randomized Group C [Marcaine Plus Exparel] |
Primary outcome
The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively.
Time frame: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cocktail, Exparel and Marcaine in people with Total Knee Arthroplasty and Pain Management, run by University of Louisville.
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: withdrawn, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively. (time frame: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.). 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 6 Apr 2017.