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Liposomal Bupivacaine in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426164
Recruitment Status : Withdrawn (Could not receive facility approval)
First Posted : April 24, 2015
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
Creighton University Medical Center
CHI Health Mercy Hospital
Information provided by (Responsible Party):
Miller Orthopedic Specialists

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Arthroplasty, Replacement, Knee Osteoarthritis Drug: Liposomal bupivacaine Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Liposomal Bupivacaine in Total Knee Arthroplasty
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Active Comparator: Liposomal bupivacaine
Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants
Drug: Liposomal bupivacaine
Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
Other Name: Exparel

Active Comparator: bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants
Drug: bupivacaine HCl, morphine, epinephrine, methylprednisolone
Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone




Primary Outcome Measures :
  1. Mean visual analog scale (VAS) pain scores [ Time Frame: Night of surgery ]
    Self-reported pain scores from 0=no pain to 10=severe pain

  2. Mean visual analog scale (VAS) pain scores [ Time Frame: Post-operative day 1 ]
    Self-reported pain scores from 0=no pain to 10=severe pain

  3. Mean visual analog scale (VAS) pain scores [ Time Frame: Post-operative day 2 ]
    Self-reported pain scores from 0=no pain to 10=severe pain

  4. Pain assessment phone call [ Time Frame: Post-operative day 3 ]
    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 :
  1. Complications [ Time Frame: Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days. ]
    Number of patients with complications



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426164


Locations
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United States, Iowa
Miller Orthopedic Specialists
Council Bluffs, Iowa, United States, 51503
Sponsors and Collaborators
Miller Orthopedic Specialists
Creighton University Medical Center
CHI Health Mercy Hospital
Investigators
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Principal Investigator: Clifford K Boese, MD Miller Orthopedic Specialists
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Responsible Party: Miller Orthopedic Specialists
ClinicalTrials.gov Identifier: NCT02426164    
Other Study ID Numbers: 633913
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: April 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Epinephrine
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists