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Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee, Arthritis, Degenerative

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Liposome Injection
Indwelling femoral nerve block
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Arthroplasty, Osteoarthritis, Femoral Nerve Blockade, Liposomal Bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Femoral Nerve Blockade

Bupivacaine Liposome Injection

Arm Description

Femoral nerve block delivered via indwelling femoral nerve catheter

Intraoperative intracapsular injection of bupivacaine liposome

Outcomes

Primary Outcome Measures

Visual Analog Pain Scale
10cm VAS scale completed by the patient at set intervals postoperatively
Oral and Intravenous Opioid Consumption
Oral and intravenous opioid use calculated in terms of morphine equivalents
Hospital for Special Surgery (HSS) Knee Scores
Standardized functional clinical score for knee symptoms

Secondary Outcome Measures

Length of Hospital Stay
Distance ambulated with physical therapy
Time to straight leg raise with physical therapy
Time to return of quadriceps function
Postoperative range of motion
Knee range of motion measure by physical therapy and in clinic
Postoperative complication rate
All intervention related complications for each arm of the study
Plasma bupivacaine concentrations
Plasma levels of bupivacaine monitored throughout hospital stay

Full Information

First Posted
January 14, 2015
Last Updated
March 7, 2017
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02341079
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Principal no longer interested in conducting study
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee, Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
Keywords
Total Knee Arthroplasty, Osteoarthritis, Femoral Nerve Blockade, Liposomal Bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral Nerve Blockade
Arm Type
Active Comparator
Arm Description
Femoral nerve block delivered via indwelling femoral nerve catheter
Arm Title
Bupivacaine Liposome Injection
Arm Type
Experimental
Arm Description
Intraoperative intracapsular injection of bupivacaine liposome
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Liposome Injection
Other Intervention Name(s)
EXPAREL
Intervention Description
Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
Intervention Type
Drug
Intervention Name(s)
Indwelling femoral nerve block
Intervention Description
Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.
Primary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
10cm VAS scale completed by the patient at set intervals postoperatively
Time Frame
0-3 months
Title
Oral and Intravenous Opioid Consumption
Description
Oral and intravenous opioid use calculated in terms of morphine equivalents
Time Frame
0-5 days (during hospitalization)
Title
Hospital for Special Surgery (HSS) Knee Scores
Description
Standardized functional clinical score for knee symptoms
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Time Frame
0-5 days
Title
Distance ambulated with physical therapy
Time Frame
0-5 days (during hospitalization)
Title
Time to straight leg raise with physical therapy
Description
Time to return of quadriceps function
Time Frame
0-5 days (during hospitalization)
Title
Postoperative range of motion
Description
Knee range of motion measure by physical therapy and in clinic
Time Frame
0-3 months
Title
Postoperative complication rate
Description
All intervention related complications for each arm of the study
Time Frame
0-3 months
Title
Plasma bupivacaine concentrations
Description
Plasma levels of bupivacaine monitored throughout hospital stay
Time Frame
0-5 days (during hospitalization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick B Morrissey, M.D.
Organizational Affiliation
Naval Medical Center San Diego Department of Orthopadic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

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Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

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