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WithdrawnNCT02341079Updated Mar 10, 2017

Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

A Phase 2/3 interventional study of Bupivacaine Liposome Injection and Indwelling femoral nerve block in Osteoarthritis, Osteoarthritis, Knee and Arthritis, Degenerative, sponsored by United States Naval Medical Center, San Diego. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by United States Naval Medical Center, San Diego · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Principal no longer interested in conducting study
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Osteoarthritis
  • Osteoarthritis, Knee
  • Arthritis, Degenerative
  • Osteoarthrosis
  • Osteoarthrosis Deformans

Keywords

  • Total Knee Arthroplasty
  • Osteoarthritis
  • Femoral Nerve Blockade
  • Liposomal Bupivacaine
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

United States Naval Medical Center, San Diego is the lead sponsor of 63 studies on the registry; 6 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age over 18 years old
  • Undergoing unilateral primary total knee arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Revision total knee arthroplasty
  • Bilateral total knee arthroplasty
  • Prior allergy or adverse reaction to local anesthetic
  • Hepatic dysfunction
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Femoral Nerve Blockade

    Femoral nerve block delivered via indwelling femoral nerve catheter

    Drug: Indwelling femoral nerve block

  • Experimental
    Bupivacaine Liposome Injection

    Intraoperative intracapsular injection of bupivacaine liposome

    Drug: Bupivacaine Liposome Injection

Interventions

  • DrugBupivacaine Liposome Injection

    Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.

    Also known as: EXPAREL

  • DrugIndwelling femoral nerve block

    Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.

06

What researchers measure

Primary outcomes

  1. Visual Analog Pain Scale

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

    Time frame: 0-3 months

  2. Oral and Intravenous Opioid Consumption

    Oral and intravenous opioid use calculated in terms of morphine equivalents

    Time frame: 0-5 days (during hospitalization)

  3. Hospital for Special Surgery (HSS) Knee Scores

    Standardized functional clinical score for knee symptoms

    Time frame: 0-3 months

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: 0-5 days

  2. Distance ambulated with physical therapy

    Time frame: 0-5 days (during hospitalization)

  3. Time to straight leg raise with physical therapy

    Time to return of quadriceps function

    Time frame: 0-5 days (during hospitalization)

  4. Postoperative range of motion

    Knee range of motion measure by physical therapy and in clinic

    Time frame: 0-3 months

  5. Postoperative complication rate

    All intervention related complications for each arm of the study

    Time frame: 0-3 months

  6. Plasma bupivacaine concentrations

    Plasma levels of bupivacaine monitored throughout hospital stay

    Time frame: 0-5 days (during hospitalization)

07

Study locations

1 site
  • Naval Medical Center San Diego
    San Diego, California 92134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02341079
Lead sponsor
United States Naval Medical Center, San Diego
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Mar 2015
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Mar 10, 2017

Study contacts

Patrick B Morrissey, M.D.
principal investigator · Naval Medical Center San Diego Department of Orthopadic Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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