Study Stopped
Principal no longer interested in conducting study
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 10, 2017
March 1, 2017
7 months
January 14, 2015
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visual Analog Pain Scale
10cm VAS scale completed by the patient at set intervals postoperatively
0-3 months
Oral and Intravenous Opioid Consumption
Oral and intravenous opioid use calculated in terms of morphine equivalents
0-5 days (during hospitalization)
Hospital for Special Surgery (HSS) Knee Scores
Standardized functional clinical score for knee symptoms
0-3 months
Secondary Outcomes (6)
Length of Hospital Stay
0-5 days
Distance ambulated with physical therapy
0-5 days (during hospitalization)
Time to straight leg raise with physical therapy
0-5 days (during hospitalization)
Postoperative range of motion
0-3 months
Postoperative complication rate
0-3 months
- +1 more secondary outcomes
Study Arms (2)
Femoral Nerve Blockade
ACTIVE COMPARATORFemoral nerve block delivered via indwelling femoral nerve catheter
Bupivacaine Liposome Injection
EXPERIMENTALIntraoperative intracapsular injection of bupivacaine liposome
Interventions
Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.
Eligibility Criteria
You may qualify if:
- Age over 18 years old
- Undergoing unilateral primary total knee arthroplasty
You may not qualify if:
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Prior allergy or adverse reaction to local anesthetic
- Hepatic dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Naval Medical Center San Diego
San Diego, California, 92134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick B Morrissey, M.D.
Naval Medical Center San Diego Department of Orthopadic Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 19, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 10, 2017
Record last verified: 2017-03