Clinical trial NCT02863120: Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
Official title: Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Bupivacaine
Osteoarthritis
Arthritis
Joint Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Lead sponsor: Texas Orthopaedics, Sports and Rehabilitation Associates
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Length of stay (LOS, in days)
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
measure: Time to ambulation (in hours)
timeFrame: 2-6 hours
Secondary outcomes:
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 0
timeFrame: 6 hours
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 1
timeFrame: 24 hours
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 2
timeFrame: 48 hours
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 3
timeFrame: 72 hours
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 4
timeFrame: 96 hours
measure: Pain as assessed by visual analog scale (VAS) on postoperative day 5
timeFrame: 120 hours
measure: Opioid consumption in oral morphine equivalents (OMEs, in milligrams)
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
measure: Postoperative complications and adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
Study officials:
affiliation: Texas Orthopedics
name: Tyler D Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References: