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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Withdrawn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
Miller Orthopedic Specialists
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 14, 2015
Last Updated
March 18, 2016
Sponsor
Miller Orthopedic Specialists
Collaborators
Creighton University Medical Center, CHI Health Mercy Hospital
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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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