- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02863120
Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
October 5, 2020 updated by: Texas Orthopaedics, Sports and Rehabilitation Associates
Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief.
The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Austin, Texas, United States, 78759
- Texas Orthopedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant female between the ages of 18-65
- Patients willing and able to sign the informed consent
- Patients able to comply with follow-up requirements including self-evaluations
- Patients requiring a primary total knee replacement
- Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
Exclusion Criteria:
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Patients with inflammatory arthritis
- Patients with a body mass index (BMI) > 40
- Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
- Current use of opioid drugs
- Patients with a history of total or unicompartmental reconstruction of the affected joint
- Patients that have had a high tibial osteotomy or femoral osteotomy
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
- Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
- Patients with knee fusion to the affected joint
- Patients with an active or suspected latent infection in or about the knee joint
- Patients that are prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants
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Other Names:
Other Names:
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Active Comparator: Adductor canal and tibial nerve block
Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block.
Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of stay (LOS, in days)
Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
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Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
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Time to ambulation (in hours)
Time Frame: 2-6 hours
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2-6 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain as assessed by visual analog scale (VAS) on postoperative day 0
Time Frame: 6 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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6 hours
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Pain as assessed by visual analog scale (VAS) on postoperative day 1
Time Frame: 24 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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24 hours
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Pain as assessed by visual analog scale (VAS) on postoperative day 2
Time Frame: 48 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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48 hours
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Pain as assessed by visual analog scale (VAS) on postoperative day 3
Time Frame: 72 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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72 hours
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Pain as assessed by visual analog scale (VAS) on postoperative day 4
Time Frame: 96 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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96 hours
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Pain as assessed by visual analog scale (VAS) on postoperative day 5
Time Frame: 120 hours
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Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
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120 hours
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Opioid consumption in oral morphine equivalents (OMEs, in milligrams)
Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
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Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
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|
Postoperative complications and adverse events
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tyler D Goldberg, MD, Texas Orthopedics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Actual)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 5, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG-EXP-160402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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