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Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02863120
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Texas Orthopaedics, Sports and Rehabilitation Associates

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: liposomal bupivacaine Drug: bupivacaine HCl Drug: Ropivacaine Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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
Drug: liposomal bupivacaine
Other Name: Exparel

Drug: bupivacaine HCl
Other Name: Marcaine

Drug: Saline
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
Drug: bupivacaine HCl
Other Name: Marcaine

Drug: Ropivacaine
Other Name: Naropin




Primary Outcome Measures :
  1. 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 ]
  2. Time to ambulation (in hours) [ Time Frame: 2-6 hours ]

Secondary Outcome Measures :
  1. Pain as assessed by visual analog scale (VAS) on postoperative day 0 [ Time Frame: 6 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  2. Pain as assessed by visual analog scale (VAS) on postoperative day 1 [ Time Frame: 24 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  3. Pain as assessed by visual analog scale (VAS) on postoperative day 2 [ Time Frame: 48 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  4. Pain as assessed by visual analog scale (VAS) on postoperative day 3 [ Time Frame: 72 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  5. Pain as assessed by visual analog scale (VAS) on postoperative day 4 [ Time Frame: 96 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  6. Pain as assessed by visual analog scale (VAS) on postoperative day 5 [ Time Frame: 120 hours ]
    Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5

  7. 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. ]
  8. Postoperative complications and adverse events [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02863120


Contacts
Contact: Andrea Torres, BS 512-439-1117 atorres@txortho.com

Locations
United States, Texas
Texas Orthopedics Recruiting
Austin, Texas, United States, 78759
Contact: Andrea Torres, BS    512-439-1117    atorres@txortho.com   
Principal Investigator: Tyler D Goldberg, MD         
Sponsors and Collaborators
Texas Orthopaedics, Sports and Rehabilitation Associates
Investigators
Principal Investigator: Tyler D Goldberg, MD Texas Orthopedics

Responsible Party: Texas Orthopaedics, Sports and Rehabilitation Associates
ClinicalTrials.gov Identifier: NCT02863120     History of Changes
Other Study ID Numbers: TG-EXP-160402
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Orthopaedics, Sports and Rehabilitation Associates:
Bupivacaine
Osteoarthritis
Arthritis
Joint Diseases
Ropivacaine
Anesthetics, Local
Anesthetics

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents