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Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

Prospective Randomized Trial Comparing Intraoperative Liposomal Bupivacaine Injection With Indwelling Femoral Nerve Blockade in Early Postoperative Pain Control for Primary Total Knee Arthroplasty

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02341079
Enrollment
0
Registered
2015-01-19
Start date
2015-03-31
Completion date
2015-10-31
Last updated
2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Total Knee Arthroplasty, Osteoarthritis, Femoral Nerve Blockade, Liposomal Bupivacaine

Brief 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.

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.

Interventions

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

DRUGIndwelling femoral nerve block

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

Sponsors

United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Pain Scale0-3 months10cm VAS scale completed by the patient at set intervals postoperatively
Oral and Intravenous Opioid Consumption0-5 days (during hospitalization)Oral and intravenous opioid use calculated in terms of morphine equivalents
Hospital for Special Surgery (HSS) Knee Scores0-3 monthsStandardized functional clinical score for knee symptoms

Secondary

MeasureTime frameDescription
Postoperative range of motion0-3 monthsKnee range of motion measure by physical therapy and in clinic
Length of Hospital Stay0-5 days
Plasma bupivacaine concentrations0-5 days (during hospitalization)Plasma levels of bupivacaine monitored throughout hospital stay
Postoperative complication rate0-3 monthsAll intervention related complications for each arm of the study
Distance ambulated with physical therapy0-5 days (during hospitalization)
Time to straight leg raise with physical therapy0-5 days (during hospitalization)Time to return of quadriceps function

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026