OsteoarthritisPhase 2/3NCT02341079
Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty
A Phase 2/3 study testing Bupivacaine Liposome Injection and Indwelling femoral nerve block in people with Osteoarthritis and Osteoarthritis, Knee, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Degenerative
- What is being tested?
- Bupivacaine Liposome Injection and Indwelling femoral nerve block
- 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
- Mar 2015to Oct 2015
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Undergoing unilateral primary total knee arthroplasty
Who cannot join
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Prior allergy or adverse reaction to local anesthetic
- Hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Prospective Randomized Trial Comparing Intraoperative Liposomal Bupivacaine Injection With Indwelling Femoral Nerve Blockade in Early Postoperative Pain Control for Primary Total Knee Arthroplasty
The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.
Read the detailed description
Postoperative pain control in total knee arthroplasty is generally managed by a multimodal approach of premedication, epidural and/or peripheral nerve blocks, narcotic medications, and anti-inflammatories. Multiple studies have evaluated the efficacy of anesthetic "cocktails" of various medications for local tissue infiltration to aide in controlling postoperative pain. A recent systematic review supported the use of local anesthetic infiltration in a single intraoperative dose as an adjunct to femoral nerve block in the relief of pain; with combinations of ropivacaine, ketorolac, and adrenaline providing the best results. Several studies noted decreases in opioid consumption and overall pain scores in the perioperative period.
A novel compound, liposomal bupivacaine (EXPAREL®, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA), has been proposed for use in total knee arthroplasty. To our knowledge, only one randomized controlled trial involving use of this compound in total knee arthroplasty has been published and was performed as a phase two dose ranging trial comparing liposomal bupivacaine to bupivacaine HCl. No statistically significant difference between the two compounds was shown, but a trend towards benefit in short term pain control was shown with EXPAREL 532mg.
Our current pain management regimen utilizes the multimodal approach of neuraxial anesthesia, indwelling femoral nerve catheter, opioids, and anti-inflammatory medications. The regional anesthesia service manages postoperative pain while the indwelling femoral nerve catheter is in place. The epidural is utilized for early postoperative analgesia and thromboprophylaxis. The epidural is discontinued on post-operative day 1 and the femoral nerve catheter is removed by the morning of postoperative day 3. Although femoral nerve catheters provide excellent pain control following TKA, there are associated disadvantages. Most notably there is inherent quadriceps weakness which places the patient at increased fall risk. To reduce the risk of falling, patients must wear a knee immobilizer with ambulation until the catheter is removed and quadriceps function has returned. This may delay the ability to actively participate in physical therapy.
The purpose of our present study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain. The investigators aim to show equivalency between the two treatment modalities. Our hypothesis is that a systematic local infiltration of liposomal bupivacaine provided intraoperatively is equally efficacious as femoral indwelling peripheral nerve blockade in immediate postoperative pain control with more rapid progression with physical therapy.
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Being tested
- Bupivacaine Liposome Injection, Indwelling femoral nerve block
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Femoral Nerve Blockade, Liposomal Bupivacaine
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome InjectionDrug
Also called EXPAREL
Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
Indwelling femoral nerve blockDrug
Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Blockade | Active comparator | Femoral nerve block delivered via indwelling femoral nerve catheter Receives: Drug: Indwelling femoral nerve block |
| Bupivacaine Liposome Injection | Experimental | Intraoperative intracapsular injection of bupivacaine liposome Receives: Drug: Bupivacaine Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
10cm VAS scale completed by the patient at set intervals postoperatively
Measured: 0-3 months
Oral and Intravenous Opioid Consumption
Oral and intravenous opioid use calculated in terms of morphine equivalents
Measured: 0-5 days (during hospitalization)
Hospital for Special Surgery (HSS) Knee Scores
Standardized functional clinical score for knee symptoms
Measured: 0-3 months
Secondary outcomes (6)
Length of Hospital Stay
Measured: 0-5 days
Distance ambulated with physical therapy
Measured: 0-5 days (during hospitalization)
Time to straight leg raise with physical therapy
Time to return of quadriceps function
Measured: 0-5 days (during hospitalization)
Postoperative range of motion
Knee range of motion measure by physical therapy and in clinic
Measured: 0-3 months
Postoperative complication rate
All intervention related complications for each arm of the study
Measured: 0-3 months
Plasma bupivacaine concentrations
Plasma levels of bupivacaine monitored throughout hospital stay
Measured: 0-5 days (during hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Why it stopped: Principal no longer interested in conducting study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patrick B Morrissey, M.D., Principal investigator, Naval Medical Center San Diego Department of Orthopadic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341079
- Sponsor's protocol ID
- NMCSD.2014.0101
- Status last verified
- Mar 2017
- First submitted
- 14 Jan 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Intraoperative Liposomal Bupivacaine Injection With Indwelling Femoral Nerve Blockade in Early Postoperative Pain Control for Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02341079
- Acronym / sponsor ID
- NMCSD.2014.0101
- Conditions
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Femoral Nerve Blockade, Liposomal Bupivacaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal no longer interested in conducting study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Jan 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 purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.
Detailed description
Postoperative pain control in total knee arthroplasty is generally managed by a multimodal approach of premedication, epidural and/or peripheral nerve blocks, narcotic medications, and anti-inflammatories. Multiple studies have evaluated the efficacy of anesthetic "cocktails" of various medications for local tissue infiltration to aide in controlling postoperative pain. A recent systematic review supported the use of local anesthetic infiltration in a single intraoperative dose as an adjunct to femoral nerve block in the relief of pain; with combinations of ropivacaine, ketorolac, and adrenaline providing the best results. Several studies noted decreases in opioid consumption and overall pain scores in the perioperative period.
A novel compound, liposomal bupivacaine (EXPAREL®, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA), has been proposed for use in total knee arthroplasty. To our knowledge, only one randomized controlled trial involving use of this compound in total knee arthroplasty has been published and was performed as a phase two dose ranging trial comparing liposomal bupivacaine to bupivacaine HCl. No statistically significant difference between the two compounds was shown, but a trend towards benefit in short term pain control was shown with EXPAREL 532mg.
Our current pain management regimen utilizes the multimodal approach of neuraxial anesthesia, indwelling femoral nerve catheter, opioids, and anti-inflammatory medications. The regional anesthesia service manages postoperative pain while the indwelling femoral nerve catheter is in place. The epidural is utilized for early postoperative analgesia and thromboprophylaxis. The epidural is discontinued on post-operative day 1 and the femoral nerve catheter is removed by the morning of postoperative day 3. Although femoral nerve catheters provide excellent pain control following TKA, there are associated disadvantages. Most notably there is inherent quadriceps weakness which places the patient at increased fall risk. To reduce the risk of falling, patients must wear a knee immobilizer with ambulation until the catheter is removed and quadriceps function has returned. This may delay the ability to actively participate in physical therapy.
The purpose of our present study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain. The investigators aim to show equivalency between the two treatment modalities. Our hypothesis is that a systematic local infiltration of liposomal bupivacaine provided intraoperatively is equally efficacious as femoral indwelling peripheral nerve blockade in immediate postoperative pain control with more rapid progression with physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Blockade | Active comparator | Drug: Indwelling femoral nerve blockFemoral nerve block delivered via indwelling femoral nerve catheter |
| Bupivacaine Liposome Injection | Experimental | Drug: Bupivacaine Liposome InjectionIntraoperative intracapsular injection of bupivacaine liposome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years old
- Undergoing unilateral primary total knee arthroplasty
Key exclusion criteria (4 listed)
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Prior allergy or adverse reaction to local anesthetic
- Hepatic dysfunction
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 |
|---|---|---|
| Bupivacaine Liposome InjectionAlso: EXPARELIntraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline. | Drug | Bupivacaine Liposome Injection |
| Indwelling femoral nerve blockFemoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine. | Drug | Femoral Nerve Blockade |
Primary outcome
Visual Analog Pain Scale
Time frame: 0-3 months
10cm VAS scale completed by the patient at set intervals postoperatively
Oral and Intravenous Opioid Consumption
Time frame: 0-5 days (during hospitalization)
Oral and intravenous opioid use calculated in terms of morphine equivalents
Hospital for Special Surgery (HSS) Knee Scores
Time frame: 0-3 months
Standardized functional clinical score for knee symptoms
6 secondary outcomes
Length of Hospital Stay
Time frame: 0-5 days
Distance ambulated with physical therapy
Time frame: 0-5 days (during hospitalization)
Time to straight leg raise with physical therapy
Time frame: 0-5 days (during hospitalization)
Postoperative range of motion
Time frame: 0-3 months
Postoperative complication rate
Time frame: 0-3 months
Plasma bupivacaine concentrations
Time frame: 0-5 days (during hospitalization)
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 10 Mar 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.
Patrick B Morrissey, M.D. principal investigator
Naval Medical Center San Diego Department of Orthopadic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine Liposome Injection and Indwelling femoral nerve block in people with Osteoarthritis and Osteoarthritis, Knee, run by United States Naval Medical Center, San Diego 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 4 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 10 Mar 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Visual Analog Pain Scale (time frame: 0-3 months). The study lists 3 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 10 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.