Trial | NCT02863120  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
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 Started
Jul 31
2016
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Last Update
Oct 08
2020

Drug liposomal bupivacaine

  • Other names: Exparel

Drug bupivacaine HCl

  • Other names: Marcaine

Drug Ropivacaine

  • Other names: Naropin

Drug Saline

Liposomal bupivacaine Active Comparator

Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants

Adductor canal and tibial nerve block Active Comparator

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

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
No Results Posted