Clinical trial NCT02341079: Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Osteoarthritis, Knee
Arthritis, Degenerative
Osteoarthrosis
Osteoarthrosis Deformans
Keywords: Total Knee Arthroplasty
Osteoarthritis
Femoral Nerve Blockade
Liposomal Bupivacaine
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2015-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: 0-3 months
measure: Oral and Intravenous Opioid Consumption
timeFrame: 0-5 days (during hospitalization)
measure: Hospital for Special Surgery (HSS) Knee Scores
timeFrame: 0-3 months
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: 0-5 days
measure: Distance ambulated with physical therapy
timeFrame: 0-5 days (during hospitalization)
measure: Time to straight leg raise with physical therapy
timeFrame: 0-5 days (during hospitalization)
measure: Postoperative range of motion
timeFrame: 0-3 months
measure: Postoperative complication rate
timeFrame: 0-3 months
measure: Plasma bupivacaine concentrations
timeFrame: 0-5 days (during hospitalization)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Naval Medical Center San Diego Department of Orthopadic Surgery
name: Patrick B Morrissey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: