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Completed

NCT Number: NCT02863120

Liposomal Bupivacaine vs Adductor Canal Block in 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Orthopedics

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal bupivacaine

Drug

Other names: Exparel

Bupivacaine HCl

Drug

Other names: Marcaine

Ropivacaine

Drug

Other names: Naropin

Saline

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Texas Orthopaedics, Sports and Rehabilitation Associates

Other

Registry information

Official study title

Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2016
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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