Liposomal Bupivacaine in Total Knee Arthroplasty
Primary Purpose
Pain, Postoperative, Arthroplasty, Replacement, Knee, Osteoarthritis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
bupivacaine HCl, morphine, epinephrine, methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial
Exclusion Criteria:
- Patients with a sensitivity to marcaine
- Pregnant or lactating women
- Non-English speaking individuals
Sites / Locations
- Miller Orthopedic Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liposomal bupivacaine
bupivacaine HCl, morphine, epinephrine, methylprednisolone
Arm Description
Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants
Outcomes
Primary Outcome Measures
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Mean visual analog scale (VAS) pain scores
Self-reported pain scores from 0=no pain to 10=severe pain
Pain assessment phone call
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
Secondary Outcome Measures
Complications
Number of patients with complications
Full Information
NCT ID
NCT02426164
First Posted
April 14, 2015
Last Updated
March 18, 2016
Sponsor
Miller Orthopedic Specialists
Collaborators
Creighton University Medical Center, CHI Health Mercy Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02426164
Brief Title
Liposomal Bupivacaine in Total Knee Arthroplasty
Official Title
Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Could not receive facility approval
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miller Orthopedic Specialists
Collaborators
Creighton University Medical Center, CHI Health Mercy Hospital
4. Oversight
5. Study Description
Brief Summary
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Arthroplasty, Replacement, Knee, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal bupivacaine
Arm Type
Active Comparator
Arm Description
Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
Arm Title
bupivacaine HCl, morphine, epinephrine, methylprednisolone
Arm Type
Active Comparator
Arm Description
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
Intervention Type
Drug
Intervention Name(s)
bupivacaine HCl, morphine, epinephrine, methylprednisolone
Intervention Description
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone
Primary Outcome Measure Information:
Title
Mean visual analog scale (VAS) pain scores
Description
Self-reported pain scores from 0=no pain to 10=severe pain
Time Frame
Night of surgery
Title
Mean visual analog scale (VAS) pain scores
Description
Self-reported pain scores from 0=no pain to 10=severe pain
Time Frame
Post-operative day 1
Title
Mean visual analog scale (VAS) pain scores
Description
Self-reported pain scores from 0=no pain to 10=severe pain
Time Frame
Post-operative day 2
Title
Pain assessment phone call
Description
Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day.
Time Frame
Post-operative day 3
Secondary Outcome Measure Information:
Title
Complications
Description
Number of patients with complications
Time Frame
Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial
Exclusion Criteria:
Patients with a sensitivity to marcaine
Pregnant or lactating women
Non-English speaking individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford K Boese, MD
Organizational Affiliation
Miller Orthopedic Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miller Orthopedic Specialists
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Liposomal Bupivacaine in Total Knee Arthroplasty
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