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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT02341079
Study groupRoleWhat they receive
Femoral Nerve BlockadeActive comparatorFemoral nerve block delivered via indwelling femoral nerve catheter
Receives: Drug: Indwelling femoral nerve block
Bupivacaine Liposome InjectionExperimentalIntraoperative 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.

  1. Visual Analog Pain Scale

    10cm VAS scale completed by the patient at set intervals postoperatively

    Measured: 0-3 months

  2. Oral and Intravenous Opioid Consumption

    Oral and intravenous opioid use calculated in terms of morphine equivalents

    Measured: 0-5 days (during hospitalization)

  3. Hospital for Special Surgery (HSS) Knee Scores

    Standardized functional clinical score for knee symptoms

    Measured: 0-3 months

Secondary outcomes (6)
  1. Length of Hospital Stay

    Measured: 0-5 days

  2. Distance ambulated with physical therapy

    Measured: 0-5 days (during hospitalization)

  3. Time to straight leg raise with physical therapy

    Time to return of quadriceps function

    Measured: 0-5 days (during hospitalization)

  4. Postoperative range of motion

    Knee range of motion measure by physical therapy and in clinic

    Measured: 0-3 months

  5. Postoperative complication rate

    All intervention related complications for each arm of the study

    Measured: 0-3 months

  6. 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.

  1. First posted19 Jan 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionOct 2015 (estimated)
  4. Study completionOct 2015 (estimated)

Why it stopped: Principal no longer interested in conducting study

Resources

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)
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

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.

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Clinical Trial NCT02341079 | AzTrials