ArthritisPhase 4NCT02011464
Evaluation Exparel Delivered in Knee Replacement
A Phase 4 study testing Exparel and Saline in people with Arthritis, run by Maimonides Medical Center at 1 site in United States.
Trial summary
Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Exparel and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3
- Patients undergoing knee replacement (total knee arthroplasty)
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
- History of pre-existing neurological disorders/neuropathy
- Morbid Obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Exparel Delivered Into the Posterior Capsule During Knee Replacement
Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief.
Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.
Read the detailed description
Objectives:
- Is to assess the efficacy of pain control of Exparel vs. controls when injected into the posterior capsular space after total knee arthroplasty
- Asses the opioid use after Exparel vs. controls
- Asses the time to simple and complex knee movement and ambulation.
- The safety of Exparel will be assessed by the occurrence of all postsurgical adverse events and serious adverse events through Day 30.
Methods:
After institutional review board (IRB) approval, 20 subjects will be consented to participate in the study. The study includes subjects undergoing total knee arthroplasty either under general or spinal anesthesia. This study will include men and women (18 - 75 years) who have American Society of Anesthesiologist physical classification status 1 - 3 and underwent total knee arthroplasty.
Subjects will be divided into two groups, Group A (control) to receive 20ml of saline while Group B (study) to receive 20ml of liposomal bupivacaine into the posterior capsular space during total knee arthroplasty. Patients from both groups will receive a femoral nerve block with catheter placement for continuous infusion of local anesthetic. All subjects will have access to rescue analgesics after surgery. Multimodal analgesia will supplement pain as per standard care by the anesthesia team. Tylenol Orally 1g three times daily (not to exceed 4g in 24hrs), oxycontin 10mg orally, twice/day, Celebrex 200 mg orally once a day and Percocet 5/325 prn will serve as this multimodal approach. The time, day and number of requests for break through (additional) analgesia will be noted by both anesthesia team and primary care team. Pain scores will be assessed using a 0 - 10 numeric scale. Pain will be assessed for the following intervals: hospital arrival, post anesthesia care unit (PACU) arrival, 2, 4, 8, 12, 24, 48, 72, hours later and after hospital discharge 10 +/- 5 days after the block. Pain inquiries will assess both posterior and anterior aspects of the knee. Pain at rest and for simple leg movements (knee extension, straight leg raise) to fully ambulatory will be noted. These assessments will be made in conjunction with rehabilitation and physical therapy specialists.
- Conditions
- Arthritis
- Being tested
- Exparel, Saline
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called Bupivacaine
Exparel is infiltrated into posterior compartment for pain control
SalineOther
Saline is infiltrated into posterior compartment for control
| Study group | Role | What they receive |
|---|---|---|
| Exparel infiltration | Experimental | Exparel infiltrated into the posterior compartment of the knee Receives: Drug: Exparel |
| Control | Placebo comparator | Saline infiltrated into posterior compartment Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain
Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.
Measured: 72 hours post-operative
Secondary outcomes (1)
Post-operative Narcotic Use
Average postoperative narcotics administered in total milligrams of morphine equivalents
Measured: 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2015
- Study completionSep 2015
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 ArthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piyush Gupta, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011464
- Sponsor's protocol ID
- 2013-11-02
- Status last verified
- Jul 2017
- First submitted
- 10 Dec 2013
- Last updated
- 8 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Exparel Delivered Into the Posterior Capsule During Knee Replacement
- ClinicalTrials.gov ID
- NCT02011464
- Acronym / sponsor ID
- 2013-11-02
- Conditions
- Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 8 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain control after knee replacement requires analgesia to both the top (anterior) and bottom (posterior) portion of the the knee. Presently we use a nerve block for the anterior portion. The investigators want to to examine if giving Exparel into the posterior portion will give better pain relief.
Hypothesis: There is no difference in, the use of analgesics or the length and quality of analgesia and no decrease in the time to be able to accomplish simple to complex knee movements using Exparel infiltration when compared to controls.
Detailed description
Objectives:
- Is to assess the efficacy of pain control of Exparel vs. controls when injected into the posterior capsular space after total knee arthroplasty
- Asses the opioid use after Exparel vs. controls
- Asses the time to simple and complex knee movement and ambulation.
- The safety of Exparel will be assessed by the occurrence of all postsurgical adverse events and serious adverse events through Day 30.
Methods:
After institutional review board (IRB) approval, 20 subjects will be consented to participate in the study. The study includes subjects undergoing total knee arthroplasty either under general or spinal anesthesia. This study will include men and women (18 - 75 years) who have American Society of Anesthesiologist physical classification status 1 - 3 and underwent total knee arthroplasty.
Subjects will be divided into two groups, Group A (control) to receive 20ml of saline while Group B (study) to receive 20ml of liposomal bupivacaine into the posterior capsular space during total knee arthroplasty. Patients from both groups will receive a femoral nerve block with catheter placement for continuous infusion of local anesthetic. All subjects will have access to rescue analgesics after surgery. Multimodal analgesia will supplement pain as per standard care by the anesthesia team. Tylenol Orally 1g three times daily (not to exceed 4g in 24hrs), oxycontin 10mg orally, twice/day, Celebrex 200 mg orally once a day and Percocet 5/325 prn will serve as this multimodal approach. The time, day and number of requests for break through (additional) analgesia will be noted by both anesthesia team and primary care team. Pain scores will be assessed using a 0 - 10 numeric scale. Pain will be assessed for the following intervals: hospital arrival, post anesthesia care unit (PACU) arrival, 2, 4, 8, 12, 24, 48, 72, hours later and after hospital discharge 10 +/- 5 days after the block. Pain inquiries will assess both posterior and anterior aspects of the knee. Pain at rest and for simple leg movements (knee extension, straight leg raise) to fully ambulatory will be noted. These assessments will be made in conjunction with rehabilitation and physical therapy specialists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel infiltration | Experimental | Drug: ExparelExparel infiltrated into the posterior compartment of the knee |
| Control | Placebo comparator | Other: SalineSaline infiltrated into posterior compartment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3
- Patients undergoing knee replacement (total knee arthroplasty)
- Subjects must be physically and mentally able to participate in the study and complete all study assessments.
- Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.
Key exclusion criteria (7 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.
- Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
- Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.
- Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
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 |
|---|---|---|
| ExparelAlso: BupivacaineExparel is infiltrated into posterior compartment for pain control | Drug | Exparel infiltration |
| SalineSaline is infiltrated into posterior compartment for control | Other | Control |
Primary outcome
Subjective Pain
Time frame: 72 hours post-operative
Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.
1 secondary outcome
Post-operative Narcotic Use
Time frame: 72 hours post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- 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.
Piyush Gupta, MD principal investigator
Maimonides Medical Center
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 Exparel and Saline in people with Arthritis, run by Maimonides Medical Center 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 4 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 8 Aug 2017. 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 8 Aug 2017). 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?
Subjective Pain (time frame: 72 hours post-operative). 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 8 Aug 2017.