Knee Osteoarthritis
Conditions
Keywords
Bupivacaine, Osteoarthritis, Arthritis, Joint Diseases, Ropivacaine, Anesthetics, Local, Anesthetics
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.
Interventions
DRUGRopivacaine
DRUGSaline
DRUGliposomal bupivacaine
DRUGbupivacaine HCl
Sponsors
Texas Orthopaedics, Sports and Rehabilitation Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of stay (LOS, in days) | Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days |
| Time to ambulation (in hours) | 2-6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed by visual analog scale (VAS) on postoperative day 2 | 48 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
| Pain as assessed by visual analog scale (VAS) on postoperative day 3 | 72 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
| Pain as assessed by visual analog scale (VAS) on postoperative day 4 | 96 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
| Pain as assessed by visual analog scale (VAS) on postoperative day 0 | 6 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
| Opioid consumption in oral morphine equivalents (OMEs, in milligrams) | Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days. | — |
| Postoperative complications and adverse events | 2 weeks | — |
| Pain as assessed by visual analog scale (VAS) on postoperative day 5 | 120 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
| Pain as assessed by visual analog scale (VAS) on postoperative day 1 | 24 hours | Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5 |
Countries
United States
Outcome results
None listed