Total Knee ArthroplastyPhase 4NCT01977339
Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty
A Phase 4 study testing Liposome Bupivacaine and Bupivacaine in people with Total Knee Arthroplasty, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Liposome Bupivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ≥18 years of age
- Scheduled to undergo primary unilateral TKA under general anesthesia.
- American Society of Anesthesiology (ASA) Physical Status I-III
- Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
- Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
- Previous participation in a liposome bupivacaine study.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
About this study
Official title: A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty
The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Liposome Bupivacaine, Bupivacaine
- Keywords
- Femoral Nerve Block, Liposomal Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome BupivacaineDrug
Also called Exparel
10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline
BupivacaineDrug
20 cc of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Liposome Bupivacaine | Experimental | Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline Receives: Drug: Liposome Bupivacaine |
| Bupivacaine | Active comparator | Single shot femoral nerve block with 20cc of 0.25% bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate consumption
Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine.
Measured: 72 hours
Secondary outcomes (1)
Post-operative VAS scores
Patients will be asked to describe the pain intensity under two circumstances: pain at rest, and pain on movement. Postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) system at 1, 4, 8, 12, 24, 48 and 72 hours. The VAS used will be the 11 point verbal response pain scale with 0 being no pain at all and 10 being the worst possible pain. The patients will be asked to rate their pain levels using this numeric scale.
Measured: 1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startMay 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: New departmental administration, loss of key study faculty
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Shariat, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977339
- Sponsor's protocol ID
- 13-0060
- Status last verified
- Apr 2017
- First submitted
- 30 Oct 2013
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01977339
- Acronym / sponsor ID
- 13-0060
- Conditions
- Total Knee Arthroplasty
- Keywords
- Femoral Nerve Block, Liposomal Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New departmental administration, loss of key study faculty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 Nov 2013 (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 purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposome Bupivacaine | Experimental | Drug: Liposome BupivacaineSingle injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline |
| Bupivacaine | Active comparator | Drug: BupivacaineSingle shot femoral nerve block with 20cc of 0.25% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, ≥18 years of age
- Scheduled to undergo primary unilateral TKA under general anesthesia.
- American Society of Anesthesiology (ASA) Physical Status I-III
- Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Key exclusion criteria (7 listed)
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Planned concurrent surgical procedure (e.g., bilateral TKA).
- Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
- Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
- Previous participation in a liposome bupivacaine 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 |
|---|---|---|
| Liposome BupivacaineAlso: Exparel10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline | Drug | Liposome Bupivacaine |
| Bupivacaine20 cc of 0.25% bupivacaine | Drug | Bupivacaine |
Primary outcome
Opiate consumption
Time frame: 72 hours
Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine.
1 secondary outcome
Post-operative VAS scores
Time frame: 1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs
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 20 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.
Ali Shariat, MD principal investigator
St. Luke's-Roosevelt Hospital 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 Liposome Bupivacaine and Bupivacaine in people with Total Knee Arthroplasty, run by St. Luke's-Roosevelt Hospital 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 5 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: withdrawn, as of the sponsor's last update on 20 Apr 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. 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?
Opiate consumption (time frame: 72 hours). 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 20 Apr 2017.